This section highlights FDA-related milestones and regulatory updates for drugs developed by Johnson & Johnson (JNJ).
Over the past two years, Johnson & Johnson has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
TAR-200, JNJ-4804, Guselkumab, STELARA, IMAAVY, Vivacity-MG3, and Icotrokinra. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
TAR-200 FDA Regulatory Timeline and Events
TAR-200 is a drug developed by Johnson & Johnson for the following indication: In patients with intermediate risk non–muscle-invasive bladder cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TAR-200
- Announced Date:
- May 5, 2026
- Indication:
- In patients with intermediate risk non–muscle-invasive bladder cancer
Announcement
ImmunityBio, Inc. announced it will present new treatment comparison results evaluating ANKTIVA® (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) versus nadofaragene firadenovec-vncg and TAR-200 in patients with non-muscle invasive bladder cancer carcinoma in situ (NMIBC CIS), with or without papillary disease, at the American Urological Association Annual Meeting (AUA 2026) in Washington, DC, May 15-18.
AI Summary
ImmunityBio announced it will present new treatment comparison results evaluating ANKTIVA® (nogapendekin alfa inbakicept‑pmln) plus Bacillus Calmette‑Guérin (BCG) versus nadofaragene firadenovec‑vncg and TAR‑200 at the American Urological Association Annual Meeting (AUA 2026) in Washington, DC, May 15–18.
The analysis focuses on patients with non‑muscle invasive bladder cancer with carcinoma in situ (NMIBC CIS), with or without papillary disease. The presentation will compare outcomes and treatment effects across these approaches, aiming to inform therapeutic choices and highlight potential combination strategies involving immune activation.
Dr. Patrick Soon‑Shiong will also present “The Role of IL15 in the Urological Setting” at ImmunityBio’s Product Theater on Saturday, May 16 at 1:30 pm EDT (booth 2701), discussing IL‑15 driven T cell and natural killer cell activation, current clinical evidence, and emerging combination approaches in bladder and prostate cancer.
Read Announcement- Drug:
- TAR-200
- Announced Date:
- July 17, 2025
- Indication:
- In patients with intermediate risk non–muscle-invasive bladder cancer
Announcement
Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) granted Priority Review to the New Drug Application (NDA) filed for TAR-200, an intravesical gemcitabine releasing system, for the treatment of patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle invasive bladder cancer (HR-NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.
AI Summary
Johnson & Johnson announced that the FDA has granted Priority Review for its New Drug Application for TAR-200, an innovative intravesical gemcitabine releasing system. This new treatment is designed for patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle invasive bladder cancer (HR-NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. The Priority Review designation highlights the potential of TAR-200 to change the way bladder cancer is treated, providing a less invasive option for patients who have limited alternatives. The FDA submission is supported by data from the Phase 2b SunRISe-1 study, which reported an 82.4 percent complete response rate and noted that a significant portion of patients remained cancer-free for at least one year after achieving a complete response. This breakthrough may offer new hope for those ineligible for radical cystectomy.
Read Announcement- Drug:
- TAR-200
- Announced Date:
- April 26, 2025
- Indication:
- In patients with intermediate risk non–muscle-invasive bladder cancer
Announcement
Johnson & Johnson announced new data from Cohort 2 of the pivotal Phase 2b SunRISe-1 study evaluating TAR-200—an intravesical gemcitabine releasing system—for patients with certain types of bladder cancer.
AI Summary
Johnson & Johnson announced encouraging new data from Cohort 2 of its pivotal Phase 2b SunRISe-1 study evaluating TAR-200. This innovative intravesical gemcitabine releasing system is designed for patients with certain types of bladder cancer who have not responded to BCG therapy. In the study, more than 82% of patients achieved a complete response without the need for reinduction, and over half of those responders remained cancer-free one year later. These findings are significant for patients with high-risk non–muscle-invasive bladder cancer with carcinoma in situ, with or without papillary tumors, who are not candidates for or choose to avoid radical cystectomy.
TAR-200 is administered directly into the bladder through a brief outpatient procedure, offering a sustained release of treatment while being well tolerated by patients. The new data highlights TAR-200’s potential to provide lasting cancer control and transform treatment outcomes for this challenging patient population.
Read Announcement- Drug:
- TAR-200
- Announced Date:
- April 21, 2025
- Indication:
- In patients with intermediate risk non–muscle-invasive bladder cancer
Announcement
Johnson & Johnson announced that new data from its leading oncology pipeline will be presented at the American Urological Association (AUA) 2025 Annual Meeting, taking place April 26-29 in Las Vegas.
AI Summary
Johnson & Johnson has announced that new data from its leading oncology pipeline will be presented at the American Urological Association (AUA) 2025 Annual Meeting in Las Vegas, from April 26 to 29. The presentation will highlight key findings from the Phase 2b SunRISe-1 study, which evaluates TAR-200 monotherapy for patients with high-risk non-muscle-invasive bladder cancer that is unresponsive to BCG treatment.
The study’s 12-month data showcase an impressive complete response rate and sustained benefits for patients treated with TAR-200, an intravesical gemcitabine releasing system. These results could offer a promising alternative for patients who have limited treatment options, potentially reducing the need for invasive procedures and improving outcomes in bladder cancer care.
Read Announcement- Drug:
- TAR-200
- Announced Date:
- January 15, 2025
- Indication:
- In patients with intermediate risk non–muscle-invasive bladder cancer
Announcement
Johnson & Johnson announced it has initiated the submission of an original New Drug Application with the U.S. Food and Drug Administration (FDA) for TAR-200 for the treatment of patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.
AI Summary
Johnson & Johnson has submitted an original New Drug Application to the U.S. FDA for TAR-200. This innovative treatment targets patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non‐muscle-invasive bladder cancer with carcinoma in situ (CIS), with or without papillary tumors.
TAR-200 is designed as an intravesical drug releasing system that delivers gemcitabine directly into the bladder. The submission is being reviewed under the FDA’s Real-Time Oncology Review (RTOR) program, which allows early data review to speed up patient access to promising treatments. The application is supported by Phase 2b SunRISe-1 study results, which highlighted a complete response rate of 83.5 percent, making TAR-200 a potential new treatment option for patients who may otherwise face radical surgery.
Read Announcement- Drug:
- TAR-200
- Announced Date:
- September 15, 2024
- Indication:
- In patients with intermediate risk non–muscle-invasive bladder cancer
Announcement
Johnson & Johnson announced additional results from the pivotal Phase 2b SunRISe-1 study, supporting the safety and efficacy profile of investigational TAR-200 for the treatment of patients with Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC).
AI Summary
Johnson & Johnson announced new findings from the pivotal Phase 2b SunRISe-1 study, which support the safety and effectiveness of the investigational drug TAR-200 for treating patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer. The study focused on patients who do not respond to BCG immunotherapy and face major treatment choices. TAR-200 is designed to slowly release gemcitabine into the bladder and was given as a single-agent treatment, showing an impressive complete response rate of 83.5 percent in 85 patients. These results indicate that most patients maintained their response, with 82 percent still responding at a median follow-up of nine months and an estimated 12-month response rate of 57.4 percent. The findings highlight TAR-200’s potential as a safe, effective, and less invasive alternative to radical cystectomy.
Read Announcement
JNJ-4804 FDA Regulatory Events
JNJ-4804 is a drug developed by Johnson & Johnson for the following indication: in patients with moderately to severely active ulcerative colitis (UC) or Crohn's disease (.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- JNJ-4804
- Announced Date:
- May 5, 2026
- Indication:
- in patients with moderately to severely active ulcerative colitis (UC) or Crohn's disease (
Announcement
Johnson & Johnson announced Phase 2b data from two studies evaluating JNJ-4804, an investigational co-antibody therapy targeting both interleukin-23 (IL-23) and tumor necrosis factor-alpha (TNF-α), in patients with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) that is refractory to systemic therapies.1,2
AI Summary
Johnson & Johnson reported Phase 2b data from two DUET studies of JNJ-4804, an investigational fixed‑dose co‑antibody that blocks interleukin‑23 (IL‑23) and tumor necrosis factor‑alpha (TNF‑α). The therapy is designed to deliver molecular synergy by targeting both pathways. The trials enrolled adults with moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD) whose disease was refractory to systemic therapies.
At Week 48, JNJ-4804 showed the highest rates of clinical and endoscopic outcomes versus golimumab, guselkumab, and placebo in a highly refractory subgroup that had an inadequate response to two or more systemic therapy classes. In UC patients in this subgroup, JNJ-4804 produced clinically meaningful improvements across multiple endpoints, with clinical remission nearly 60% higher than the closest comparator. Safety was generally consistent with the known profiles of the component monotherapies. These results support advancing JNJ-4804 into Phase 3 DUET ENCORE‑CD and ENCORE‑UC trials.
Read Announcement
Guselkumab FDA Regulatory Timeline and Events
Guselkumab is a drug developed by Johnson & Johnson for the following indication: For Treatment Of Adults With Moderately To Severely Active Ulcerative Colitis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Guselkumab
- Announced Date:
- May 5, 2026
- Indication:
- For Treatment Of Adults With Moderately To Severely Active Ulcerative Colitis
Announcement
Johnson & Johnson announced results from the Phase 3 FUZION study evaluating TREMFYA® (guselkumab) in adults with active perianal fistulizing Crohn's disease (CD).
AI Summary
Johnson & Johnson announced Phase 3 FUZION study results evaluating TREMFYA (guselkumab) in adults with active perianal fistulizing Crohn’s disease. At Week 24, TREMFYA produced significantly higher rates of combined fistula remission—complete external closure of draining fistulas and absence of fluid collection on MRI—compared with placebo. Both dosing regimens were statistically superior: 100 mg every 8 weeks (p=0.007) and 200 mg every 4 weeks (p=0.013). Combined remission was measured in patients with fistulas larger than 2 cm in at least two of three dimensions, confirmed by a blinded central MRI review.
This trial, the first of its kind in 20 years, was presented as late-breaking data at Digestive Disease Week 2026. Adverse events through 24 weeks were consistent with TREMFYA’s known safety profile and no new safety signals were reported. TREMFYA is developed by Janssen Biotech, and Johnson & Johnson holds exclusive worldwide marketing rights. The results suggest TREMFYA may become a new treatment option for adults with this severe Crohn’s manifestation.
Read Announcement- Drug:
- Guselkumab
- Announced Date:
- October 7, 2025
- Indication:
- For Treatment Of Adults With Moderately To Severely Active Ulcerative Colitis
Announcement
Johnson & Johnson announced new 48-week data from the Phase 3 ASTRO study evaluating TREMFYA® (guselkumab) subcutaneous (SC) induction and maintenance therapy in adults with moderately to severely active ulcerative colitis (UC).
AI Summary
Johnson & Johnson announced new 48-week results from the Phase 3 ASTRO study. This randomized, placebo-controlled, multicenter trial enrolled 418 adults with moderately to severely active ulcerative colitis. Patients received guselkumab (TREMFYA) 400 mg subcutaneous induction followed by maintenance doses of 100 mg every eight weeks or 200 mg every four weeks.
At Week 48, TREMFYA 100 mg q8w achieved 36.7% clinical remission and 25.9% endoscopic remission versus 7.2% and 5% for placebo. The 200 mg q4w group reached 42.9% clinical remission and 26.4% endoscopic remission. Symptomatic remission rates were 47.5% and 53.6%, respectively, compared with 14.4% for placebo.
These regimens led to meaningful improvements across clinical and endoscopic measures compared with placebo and benefits were seen in both biologic-naïve and biologic-refractory subgroups. Safety through Week 48 was consistent with the known TREMFYA profile.
TREMFYA is the only IL-23 inhibitor to offer a fully subcutaneous induction and maintenance regimen, delivering lasting clinical and endoscopic benefits with the flexibility of at-home injections.
Read Announcement- Drug:
- Guselkumab
- Announced Date:
- September 29, 2025
- Indication:
- For Treatment Of Adults With Moderately To Severely Active Ulcerative Colitis
Announcement
Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved TREMFYA® (guselkumab) for the treatment of children six years and older who also weigh at least 40 kg with moderate to severe plaque psoriasis (PsO), who are candidates for systemic therapy or phototherapy, or active psoriatic arthritis (PsA).
AI Summary
Johnson & Johnson announced that the U.S. Food and Drug Administration has approved TREMFYA® (guselkumab) for children six years and older who weigh at least 40 kg with moderate to severe plaque psoriasis or active psoriatic arthritis, and who are candidates for systemic therapy or phototherapy. TREMFYA® is the first IL-23 inhibitor approved for these pediatric conditions.
The approval was based on the Phase 3 PROTOSTAR study. At Week 16, 56 percent of pediatric patients receiving TREMFYA® achieved a 90 percent improvement in the Psoriasis Area Severity Index (PASI 90) versus 16 percent on placebo. Sixty-six percent reached clear or almost clear skin (IGA 0/1) compared to 16 percent with placebo, and nearly 40 percent had complete clearance (IGA 0) versus 4 percent. Active psoriatic arthritis approval was supported by pharmacokinetic analyses extrapolated from adult and pediatric studies.
TREMFYA® is given as a 100 mg subcutaneous injection at Week 0, Week 4, and every eight weeks thereafter. This approval offers new treatment options for the approximately 20,000 children diagnosed with plaque psoriasis and 14,000 with psoriatic arthritis each year.
Read Announcement- Drug:
- Guselkumab
- Announced Date:
- September 19, 2025
- Indication:
- For Treatment Of Adults With Moderately To Severely Active Ulcerative Colitis
Announcement
Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved a subcutaneous (SC) induction regimen of TREMFYA® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC).
AI Summary
Johnson & Johnson announced FDA approval of a subcutaneous induction regimen of TREMFYA (guselkumab) for adults with moderately to severely active ulcerative colitis. TREMFYA is the first and only interleukin-23 inhibitor to offer both subcutaneous and intravenous induction options for the treatment of ulcerative colitis.
The approval is based on the Phase 3 ASTRO trial, where adults receiving 400 mg subcutaneous doses at Weeks 0, 4, and 8 achieved clinical remission (26% vs. 7%) and endoscopic improvement (36% vs. 12%) at Week 12 compared with placebo. Benefits appeared as early as two weeks and matched those seen with intravenous induction. Maintenance dosing can be 100 mg every eight weeks or 200 mg every four weeks. Self-administration of TREMFYA from the start of treatment gives patients and providers greater flexibility.
Read Announcement- Drug:
- Guselkumab
- Announced Date:
- August 29, 2025
- Indication:
- For Treatment Of Adults With Moderately To Severely Active Ulcerative Colitis
Announcement
Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval to include new evidence in the TREMFYA® (guselkumab) label for the inhibition of progression of structural damage in adults with active psoriatic arthritis (PsA).
AI Summary
Johnson & Johnson announced it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration seeking FDA approval to update the TREMFYA® (guselkumab) label. The update would include new evidence showing that TREMFYA® can inhibit the progression of structural joint damage in adults living with active psoriatic arthritis.
The submission is based on 24-week results from the Phase 3b APEX study, which found that TREMFYA® met its primary endpoint by reducing joint symptoms (ACR20) and its major secondary endpoint by significantly slowing structural damage as measured by the modified van der Heijde-Sharp score compared to placebo in biologic-naïve patients. These findings were presented at the EULAR 2025 Congress.
If approved, TREMFYA® would become the first and only dual-acting IL-23 inhibitor proven to both control symptoms and meaningfully slow joint damage progression in adults with active psoriatic arthritis.
Read Announcement- Drug:
- Guselkumab
- Announced Date:
- July 29, 2025
- Indication:
- For Treatment Of Adults With Moderately To Severely Active Ulcerative Colitis
Announcement
Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval to include new evidence in the TREMFYA® (guselkumab) label for the inhibition of progression of structural damage in adults with active psoriatic arthritis (PsA).
AI Summary
Johnson & Johnson announced it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for TREMFYA® (guselkumab). This application asks the agency to update the TREMFYA label with new data showing that the therapy can slow structural damage in adults with active psoriatic arthritis (PsA).
The request is based on findings from Phase 3 DISCOVER studies, which showed patients treated with TREMFYA experienced significantly less radiographic progression of joint damage compared with placebo. These results suggest TREMFYA not only reduces symptoms like joint pain and swelling but also helps protect against long-term structural harm linked to PsA.
If approved, the label update would be the first PsA indication for TREMFYA related to structural damage inhibition. Johnson & Johnson says the updated label could help healthcare providers make better-informed treatment decisions and improve outcomes for adults living with active PsA.
Read Announcement- Drug:
- Guselkumab
- Announced Date:
- June 11, 2025
- Indication:
- For Treatment Of Adults With Moderately To Severely Active Ulcerative Colitis
Announcement
Johnson & Johnson announced findings from the Phase 3b APEX study showing that TREMFYA® (guselkumab) significantly reduced both signs and symptoms of active psoriatic arthritis (PsA) and inhibited progression of joint structural damage at 24 weeks compared to placebo.1
AI Summary
Johnson & Johnson announced new findings from the Phase 3b APEX study, which showed that TREMFYA® (guselkumab) significantly reduced both the signs and symptoms of active psoriatic arthritis (PsA) and slowed the progression of joint structural damage at 24 weeks compared to placebo. The study used the PsA modified van der Heijde-Sharp (vdH-S) score and found that the average score change was substantially lower for patients treated with TREMFYA®, indicating less joint damage over time. In addition, more than 40% of TREMFYA®-treated patients reached the ACR50 response level, showing marked improvements in joint conditions.
These results highlight TREMFYA® as an effective first-line option for managing PsA by addressing both joint and skin symptoms, making it the only IL-23 inhibitor in its class proven to inhibit joint damage progression. The study supports the medication's established safety profile and offers valuable new insights for the psoriatic arthritis community.
Read Announcement- Drug:
- Guselkumab
- Announced Date:
- May 5, 2025
- Indication:
- For Treatment Of Adults With Moderately To Severely Active Ulcerative Colitis
Announcement
Johnson & Johnson announced new data from the Phase 3 ASTRO study evaluating TREMFYA® (guselkumab) subcutaneous (SC) induction therapy in adults with moderately to severely active ulcerative colitis (UC).
AI Summary
Johnson & Johnson announced encouraging Week 24 data from the Phase 3 ASTRO study that evaluated TREMFYA® (guselkumab) subcutaneous induction therapy in adults with moderately to severely active ulcerative colitis (UC). The study showed that both TREMFYA® dosing regimens—100 mg every eight weeks and 200 mg every four weeks—led to significantly higher rates of clinical remission, symptomatic remission, endoscopic improvement, and overall clinical response compared to placebo. These improvements indicate that the subcutaneous method offers effectiveness similar to intravenous induction. In addition, subgroup analyses revealed that TREMFYA® performed well in patients who were either treatment-naïve or had been exposed to advanced therapies such as biologics and JAK inhibitors. The safety results were in line with the established profile of TREMFYA®, highlighting its potential as a flexible, patient-friendly, self-administered treatment option for UC.
Read Announcement- Drug:
- Guselkumab
- Announced Date:
- April 4, 2025
- Indication:
- For Treatment Of Adults With Moderately To Severely Active Ulcerative Colitis
Announcement
Johnson & Johnson announced that the TREMFYA® (guselkumab) Phase 3b APEX study achieved both its primary endpoint (ACR20a) of reducing signs and symptoms and its major secondary endpoint of reducing progression of structural damage as measured by radiographic progression at 24 weeks, in adults living with active psoriatic arthritis (PsA), compared to placebo.1
AI Summary
Johnson & Johnson announced that its TREMFYA® (guselkumab) Phase 3b APEX study met both its primary and major secondary endpoints in adults with active psoriatic arthritis (PsA). In this study, TREMFYA® achieved an ACR20 response—a measure showing at least 20% improvement in tender and swollen joint counts, among other criteria—which demonstrated a significant reduction in the patients’ signs and symptoms. Additionally, the study found that TREMFYA® significantly reduced the progression of structural damage, as measured by radiographic assessments at 24 weeks, compared to placebo.
The positive topline results suggest that TREMFYA® can effectively address both inflammation and the structural worsening of joints in individuals with active PsA, reinforcing its role as a first-line treatment option. The safety profile was consistent with previous clinical findings, and no new safety issues were observed during the study period.
Read Announcement- Drug:
- Guselkumab
- Announced Date:
- March 20, 2025
- Indication:
- For Treatment Of Adults With Moderately To Severely Active Ulcerative Colitis
Announcement
Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved TREMFYA® (guselkumab), the first and only IL-23 inhibitor offering both subcutaneous (SC) and intravenous (IV) induction options, for the treatment of adults with moderately to severely active Crohn's disease (CD), a chronic inflammatory condition of the gastrointestinal tract.1
AI Summary
Johnson & Johnson announced that the U.S. FDA has approved TREMFYA® (guselkumab) for adults with moderately to severely active Crohn’s disease. TREMFYA® is the first and only IL-23 inhibitor offering both subcutaneous (SC) and intravenous (IV) induction options, giving patients and healthcare providers a much-needed choice in managing this chronic inflammatory condition of the gastrointestinal tract. The dual administration methods provide flexibility; the fully subcutaneous regimen allows for convenient self-administration, while the IV option meets the needs of patients requiring alternate delivery. This approval is backed by robust Phase 3 studies, which demonstrated significant improvements in clinical and endoscopic outcomes. With TREMFYA® now approved for Crohn’s disease, it expands treatment possibilities for those who have not benefited from conventional therapies, marking a milestone in addressing the unmet needs in inflammatory bowel disease management.
Read Announcement- Drug:
- Guselkumab
- Announced Date:
- February 21, 2025
- Indication:
- For Treatment Of Adults With Moderately To Severely Active Ulcerative Colitis
Announcement
Johnson & Johnson announced data from the Phase 3 ASTRO study of TREMFYA® (guselkumab) subcutaneous (SC) induction therapy in adults with moderately to severely active ulcerative colitis (UC) at the 20th Congress of the European Crohn's and Colitis Organization (ECCO).
AI Summary
Johnson & Johnson announced promising data from the Phase 3 ASTRO study at the 20th ECCO meeting. The study evaluated TREMFYA® (guselkumab) as a subcutaneous (SC) induction therapy for adults with moderately to severely active ulcerative colitis. Results at Week 12 showed that the SC treatment achieved both primary and all secondary endpoints, demonstrating statistically significant and clinically meaningful improvements compared to placebo. The study noted improvements in clinical remission, clinical response, and endoscopic outcomes that mirror those seen with the intravenous (IV) induction regimen. Safety data were consistent with the established profile of TREMFYA®, with similar rates of adverse events between the treatment and placebo groups. The ability to use a fully SC regimen may provide a flexible and convenient treatment option, especially for patients with busy lifestyles, potentially transforming the UC treatment landscape.
Read Announcement- Drug:
- Guselkumab
- Announced Date:
- December 2, 2024
- Indication:
- For Treatment Of Adults With Moderately To Severely Active Ulcerative Colitis
Announcement
Johnson & Johnson announced the submission of two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) seeking approval of TREMFYA® (guselkumab) for the treatment of children 6 years and older with moderate-to-severe plaque psoriasis (PsO) and children 5 years of age and older with active juvenile psoriatic arthritis (jPsA).a
AI Summary
Johnson & Johnson has submitted two supplemental Biologics License Applications (sBLAs) to the U.S. FDA seeking to expand the use of TREMFYA® (guselkumab). One application targets children aged 6 years and older with moderate-to-severe plaque psoriasis, while the other is for children 5 years and older with active juvenile psoriatic arthritis (jPsA). The plaque psoriasis submission is supported by data from the Phase 3 PROTOSTAR study, along with pharmacokinetic data extrapolated from the VOYAGE 1 and 2 adult studies. For the jPsA application, the company used pharmacokinetic extrapolation from adult psoriatic arthritis studies DISCOVER 1 and 2 plus supportive efficacy and safety data from PROTOSTAR. This submission underscores Johnson & Johnson’s commitment to improving care for pediatric patients facing skin and joint conditions, aiming to bridge a significant treatment gap for these young patients.
Read Announcement- Drug:
- Guselkumab
- Announced Date:
- November 22, 2024
- Indication:
- For Treatment Of Adults With Moderately To Severely Active Ulcerative Colitis
Announcement
Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of a subcutaneous (SC) induction regimen of TREMFYA® (guselkumab) for the treatment of adults with moderately to severely active UC.
AI Summary
Johnson & Johnson has submitted a supplemental Biologics License Application (sBLA) to the U.S. FDA for a new subcutaneous (SC) induction regimen of TREMFYA® (guselkumab) to treat adults with moderately to severely active ulcerative colitis (UC). This filing marks a potential shift from the traditional intravenous induction method by offering a SC option, which could simplify treatment for UC patients. The decision is supported by data from the Phase 3 ASTRO study, where patients receiving a 400 mg SC induction dose at Weeks 0, 4, and 8 achieved statistically significant clinical remission at Week 12, along with meeting all secondary endpoints. If approved, TREMFYA® will be the first IL-23 inhibitor to possibly provide a fully SC induction and maintenance regimen, giving patients and healthcare providers greater flexibility and convenience in managing UC treatment.
Read Announcement- Drug:
- Guselkumab
- Announced Date:
- September 11, 2024
- Indication:
- For Treatment Of Adults With Moderately To Severely Active Ulcerative Colitis
Announcement
- Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved TREMFYA® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC), a chronic disease of the large intestine in which the lining of the colon becomes inflamed.
AI Summary
Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved TREMFYA® (guselkumab) for treating adults with moderately to severely active ulcerative colitis (UC). This chronic condition causes inflammation and damage to the colon’s lining. TREMFYA® is the first fully-human, dual-acting monoclonal antibody approved to treat UC, working by blocking interleukin-23 (IL-23) and binding to CD64 on cells that produce IL-23, a key component driving inflammation in UC. Data from the QUASAR study showed that TREMFYA® led to significant improvements in endoscopic remission, which means the colon’s lining appeared normal after one year of treatment. The new FDA approval highlights TREMFYA®’s well-established safety profile and marks an important advancement in providing effective treatment options for patients struggling with this challenging inflammatory bowel disease.
Read Announcement
STELARA FDA Regulatory Events
STELARA is a drug developed by Johnson & Johnson for the following indication: For the treatment of pediatric Crohn’s disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- STELARA
- Announced Date:
- May 1, 2026
- Indication:
- For the treatment of pediatric Crohn’s disease
Announcement
Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) approved STELARA®(ustekinumab) for the treatment of patients two years and older with moderately to severely active Crohn’s disease (CD).1
Read Announcement- Drug:
- STELARA
- Announced Date:
- June 17, 2025
- Indication:
- For the treatment of pediatric Crohn’s disease
Announcement
Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking to expand approval of STELARA® (ustekinumab) for the treatment of children two years and older with moderately to severely active Crohn’s disease (CD).
Read Announcement
IMAAVY FDA Regulatory Timeline and Events
IMAAVY is a drug developed by Johnson & Johnson for the following indication: For the treatment of generalized myasthenia gravis (gMG).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- IMAAVY
- Announced Date:
- April 27, 2026
- Indication:
- For the treatment of generalized myasthenia gravis (gMG).
Announcement
Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the supplemental Biologics License Application (sBLA) for IMAAVY® (nipocalimab-aahu),c confirming the urgent need for treatment options in warm autoimmune hemolytic anemia (wAIHA).
AI Summary
Johnson & Johnson announced today that the U.S. Food and Drug Administration has granted Priority Review to the supplemental Biologics License Application (sBLA) for IMAAVY (nipocalimab‑aahu), confirming an urgent need for new treatments for warm autoimmune hemolytic anemia (wAIHA). Priority Review speeds the FDA review process for medicines that may offer meaningful improvements in safety or effectiveness for serious conditions.
wAIHA is a life‑threatening disorder in which harmful immunoglobulin G (IgG) autoantibodies attach to and destroy red blood cells, causing severe, debilitating anemia. Patients can experience profound fatigue, shortness of breath, and other complications from low hemoglobin and red cell loss.
IMAAVY is designed to target the underlying cause by reducing circulating IgG, including the autoantibodies that drive wAIHA, while aiming to preserve critical immune functions. Nipocalimab is being studied across multiple antibody‑driven diseases as part of Johnson & Johnson’s broader effort to advance transformational immunology therapies.
Read Announcement- Drug:
- IMAAVY
- Announced Date:
- February 24, 2026
- Indication:
- For the treatment of generalized myasthenia gravis (gMG).
Announcement
Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA), seeking approval of IMAAVY® (nipocalimab-aahu) as the first-ever treatment for patients with warm autoimmune hemolytic anemia (wAIHA).b
AI Summary
Johnson & Johnson said it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration seeking approval of IMAAVY (nipocalimab‑aahu) as the first-ever treatment for warm autoimmune hemolytic anemia (wAIHA). Data from the pivotal ENERGY trial showed IMAAVY produced a rapid and durable hemoglobin response, and more patients treated with IMAAVY experienced rapid, sustained improvement in fatigue as measured by the FACIT‑Fatigue scale. These improvements are meaningful to patients, and the company said full ENERGY trial results are forthcoming. If approved, IMAAVY would become the first FDA‑approved therapy for this condition.
wAIHA is a rare, heterogeneous, and potentially life‑threatening disease in which IgG autoantibodies bind to and destroy red blood cells, causing severe anemia and fatigue. Currently there are no FDA‑approved therapies for wAIHA. The legal manufacturer of IMAAVY is Janssen Biotech, Inc.
Read Announcement- Drug:
- IMAAVY
- Announced Date:
- October 29, 2025
- Indication:
- For the treatment of generalized myasthenia gravis (gMG).
Announcement
Johnson & Johnson announced plans to initiate the first head-to-head study comparing FcRn blockers for patients with generalized myasthenia gravis (gMG), which aims to affirm IMAAVY™ (nipocalimab-aahu) as the FcRn blocker of choice for appropriate gMG patients.
AI Summary
Johnson & Johnson plans to launch EPIC, the first head-to-head trial comparing two FcRn blockers in adults with generalized myasthenia gravis (gMG). By pitting IMAAVY™ against efgartigimod, the company aims to establish IMAAVY as the preferred FcRn blocker for eligible gMG patients.
EPIC is a Phase 3b, randomized, open-label study enrolling gMG patients who have never received FcRn therapy. Participants will receive IMAAVY or efgartigimod, with a treatment-switch arm moving those on efgartigimod to IMAAVY. The study’s goals are to measure IgG reductions and assess sustained disease control using MG-ADL and QMG scores 8–12 weeks after treatment starts.
Johnson & Johnson will present EPIC’s design alongside Vibrance-MG pediatric data showing IMAAVY achieved 72 weeks of sustained IgG reduction, durable disease control and no new safety concerns. These findings could help doctors choose and sequence FcRn blockers for gMG treatment.
Read Announcement- Drug:
- IMAAVY
- Announced Date:
- June 23, 2025
- Indication:
- For the treatment of generalized myasthenia gravis (gMG).
Announcement
Johnson & Johnson announced new data from an indirect treatment comparison (ITC) that showed consistent and sustained disease control with IMAAVY™ (nipocalimab-aahu) versus other approved FcRn blockers in adults with generalized myasthenia gravis (gMG).
AI Summary
Johnson & Johnson announced new data from an indirect treatment comparison (ITC) showing that IMAAVY™ (nipocalimab-aahu) provided consistent and sustained disease control in adults with generalized myasthenia gravis (gMG). The analysis, which included pivotal Phase 3 data from the Vivacity-MG3 study, found that patients experienced comparable onset of symptom relief at Week 1 and significant improvements in MG-ADL scores up to 24 weeks compared to other approved FcRn blockers.
This sustained control of disease symptoms is critical for managing a chronic condition like gMG. IMAAVY™’s biweekly dosing regimen offers a predictable and convenient schedule, which can assist both patients and healthcare providers in planning long-term treatment. The ITC results add to the growing body of evidence supporting IMAAVY™ as an effective treatment option for those living with gMG.
Read Announcement- Drug:
- IMAAVY
- Announced Date:
- April 30, 2025
- Indication:
- For the treatment of generalized myasthenia gravis (gMG).
Announcement
Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved IMAAVY™ (nipocalimab-aahu), a human FcRn-blocking monoclonal antibody, for the treatment of generalized myasthenia gravis (gMG).
AI Summary
Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved IMAAVY™ (nipocalimab-aahu), the first human FcRn-blocking monoclonal antibody for generalized myasthenia gravis (gMG) treatment. This approval covers both adults and pediatric patients 12 years and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific kinase (MuSK) antibody positive. IMAAVY works by rapidly and substantially reducing immunoglobulin G (IgG) levels, one of the root causes of gMG, which helps to bring lasting disease control and symptom relief. Clinical studies have demonstrated that patients experienced improved daily functions such as chewing, swallowing, speaking, and breathing, with benefits extending up to 20 months. This new treatment offers hope to those facing the unpredictable challenges of gMG by providing a much-needed option for sustained disease management and improved quality of life.
Read Announcement
Vivacity-MG3 FDA Regulatory Events
Vivacity-MG3 is a drug developed by Johnson & Johnson for the following indication: For myasthenia gravis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Vivacity-MG3
- Announced Date:
- April 22, 2026
- Indication:
- For myasthenia gravis
Announcement
Johnson & Johnson announced new data from the Phase 3 Vivacity-MG3 study and ongoing open label extension (OLE) in a broad population of antibody-positive (including anti-AChR+a and anti-MuSK+b) adults with generalized myasthenia gravis (gMG) reinforcing the efficacy, sustained disease control and proven safety profile of IMAAVY® (nipocalimab-aahu).
AI Summary
Johnson & Johnson reported new Phase 3 Vivacity‑MG3 and ongoing open‑label extension data showing IMAAVY (nipocalimab‑aahu) provided sustained clinical improvements and reductions in total IgG through 120 weeks in antibody‑positive adults with generalized myasthenia gravis, including anti‑AChR+ and anti‑MuSK+ patients. These long follow‑up results reinforce the drug’s efficacy and sustained disease control in a broad patient group.
A post‑hoc analysis of the 24‑week double‑blind phase found that patients who achieved sustained minimal symptom expression (MSE) had greater quality‑of‑life gains (MG‑QoL‑15r) than those with only transient MSE. After the double‑blind portion, patients entered the OLE; the 120‑week observation is among the longest reported for any FcRn blocker in gMG, and 96‑week data continued to support durable benefit.
The EPIC head‑to‑head study of IMAAVY versus another FcRn blocker is now enrolling. Across the Phase 3 and OLE results, IMAAVY’s efficacy, durable disease control, and proven safety profile were reinforced in this antibody‑positive adult population.
Read Announcement
Icotrokinra FDA Regulatory Timeline and Events
Icotrokinra is a drug developed by Johnson & Johnson for the following indication: For adults and adolescents with plaque psoriasis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Icotrokinra
- Announced Date:
- March 28, 2026
- Indication:
- For adults and adolescents with plaque psoriasis
Announcement
Protagonist Therapeutics, announced new one-year Phase 3 results for ICOTYDE™ (icotrokinra) were presented at the 2026 American Academy of Dermatology (AAD) Annual Meeting.
AI Summary
Protagonist Therapeutics reported new one-year Phase 3 results for ICOTYDE (icotrokinra) presented at the 2026 American Academy of Dermatology Annual Meeting. The data show lasting skin clearance and a favorable safety profile for this once-daily oral pill for moderate-to-severe plaque psoriasis. ICOTYDE is described as the first oral peptide that specifically targets the IL-23 receptor, a key driver of psoriasis inflammation.
In adolescents through Week 52, nearly 60% of those treated achieved completely clear skin and 86% reached PASI 90 (about 90% improvement). Importantly, 92% of responders maintained their PASI 90 benefit from Week 24 to Week 52. No new safety signals were identified over one year of treatment.
The ICONIC Phase 3 program includes five pivotal studies and additional trials are underway in psoriatic arthritis, ulcerative colitis, and Crohn’s disease. Protagonist continues to advance its oral peptide platform and remains in collaboration with Johnson & Johnson on ICOTYDE’s development and commercialization.
Read Announcement- Drug:
- Icotrokinra
- Announced Date:
- March 18, 2026
- Indication:
- For adults and adolescents with plaque psoriasis
Announcement
Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved ICOTYDE™ (icotrokinra), an interleukin-23 (IL-23) receptor antagonist for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg who are candidates for systemic therapy or phototherapy.
AI Summary
Johnson & Johnson announced FDA approval of ICOTYDE (icotrokinra), an IL-23 receptor antagonist, for treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years and older who weigh at least 40 kg and are candidates for systemic therapy or phototherapy. ICOTYDE is the first oral peptide that targets the IL-23 receptor and is taken once daily as a 200 mg pill with water upon waking, 30 minutes before food. Trials showed high rates of complete skin clearance and a favorable safety profile.
The approval is supported by the ICONIC Phase 3 program, which included five studies in patients 12 and older. ICOTYDE can cause serious side effects, including infections; patients should tell their healthcare provider about medical conditions and medicines they take. For full prescribing information, consult the product labeling or the company website.
Read Announcement- Drug:
- Icotrokinra
- Announced Date:
- October 27, 2025
- Indication:
- For adults and adolescents with plaque psoriasis
Announcement
Johnson & Johnson announced Week 28 results from the Phase 2b ANTHEM-UC study of icotrokinra, a first-in-class investigational targeted oral peptide that precisely blocks the IL-23 receptor, in adults with moderately to severely active ulcerative colitis (UC).
AI Summary
Johnson & Johnson announced Week 28 results from the Phase 2b ANTHEM-UC study of icotrokinra, a first-in-class targeted oral peptide that precisely blocks the IL-23 receptor in adults with moderately to severely active ulcerative colitis.
At Week 28, all three doses (100 mg, 200 mg, 400 mg) showed higher rates of clinical response, clinical remission, and endoscopic improvement compared with placebo.
Specifically, 31.7% of patients achieved clinical remission and 38.1% had endoscopic improvement versus 9.5% and 11.1% with placebo. These sustained results underscore icotrokinra’s potential and will be presented among 23 Johnson & Johnson abstracts at the 2025 American College of Gastroenterology meeting.
Adverse events and serious adverse events were similar across icotrokinra and placebo groups, indicating a favorable safety profile with once-daily oral dosing. The Week 28 findings support advancing icotrokinra to Phase 3 trials in both ulcerative colitis and Crohn’s disease.
Read Announcement- Drug:
- Icotrokinra
- Announced Date:
- October 24, 2025
- Indication:
- For adults and adolescents with plaque psoriasis
Announcement
Johnson & Johnson announced new long-term 52-week data from the Phase 3 ICONIC-TOTAL studya evaluating icotrokinra, a first-in-class investigational targeted oral peptide that precisely blocks the IL-23 receptor, in adults and pediatric patients 12 years of age and older (adolescents) with plaque psoriasis (PsO) affecting high-impact sites.
AI Summary
Johnson & Johnson announced new 52-week data from the Phase 3 ICONIC-TOTAL study of icotrokinra, a first-in-class oral peptide that precisely blocks the IL-23 receptor. The trial included adults and adolescents (12 years and older) with moderate-to-severe plaque psoriasis at high-impact sites—scalp, genitals, hands and feet. By Week 52, 72% of patients with scalp psoriasis and 85% with genital psoriasis achieved clear or almost clear skin, while the rate for hand/foot psoriasis rose from 42% at Week 16 to 62% at Week 52.
Overall skin clearance was durable: 67% of patients maintained clear or almost clear skin (IGA 0/1) through one year, with 44% reaching full clearance (IGA 0). Safety findings remained consistent with earlier results, revealing no new concerns over 52 weeks. Presented at the 2025 Fall Clinical Dermatology Conference, these outcomes underscore icotrokinra’s promise as a convenient once-daily pill offering targeted precision, strong long-term efficacy and a favorable safety profile in plaque psoriasis management.
Read Announcement- Drug:
- Icotrokinra
- Announced Date:
- October 7, 2025
- Indication:
- For adults and adolescents with plaque psoriasis
Announcement
Johnson & Johnson announced additional Week 12 results from the Phase 2b ANTHEM-UC study of icotrokinra, a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor, in adults with moderately to severely active ulcerative colitis (UC).
AI Summary
Johnson & Johnson announced additional Week 12 results from the Phase 2b ANTHEM-UC study of icotrokinra, a first-in-class investigational oral peptide that selectively blocks the IL-23 receptor in adults with moderately to severely active ulcerative colitis. All three once-daily dose groups (400 mg, 200 mg, 100 mg) met the primary endpoint of clinical response, with the 400 mg group achieving a 63.5% response versus 27% for placebo (p<0.001).
Secondary endpoints also showed significant benefits. In the 400 mg arm, 30.2% of patients reached clinical remission, 46.0% achieved symptomatic remission, and 36.5% had endoscopic improvement (p≤0.006 versus placebo). The 200 mg and 100 mg doses delivered meaningful improvements across these measures compared to placebo.
Icotrokinra was generally well tolerated, with similar rates of adverse events across all doses and placebo. These findings underscore the potential of once-daily icotrokinra as a new oral treatment option for patients with ulcerative colitis and support the initiation of Phase 3 ICONIC-UC studies.
Read Announcement- Drug:
- Icotrokinra
- Announced Date:
- July 21, 2025
- Indication:
- For adults and adolescents with plaque psoriasis
Announcement
Johnson & Johnson announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking the first approval of icotrokinra, a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor for the treatment of adults and pediatric patients 12 years of age and older with moderate to severe plaque psoriasis (PsO).
AI Summary
Johnson & Johnson announced it submitted a New Drug Application to the FDA for icotrokinra, a first-in-class oral peptide that selectively blocks the IL-23 receptor. This investigational pill is designed for adults and patients aged 12 and older with moderate-to-severe plaque psoriasis.
The filing includes data from four Phase 3 ICONIC studies, all of which met co-primary endpoints for clear or almost clear skin and at least 90% improvement in psoriasis area and severity. In head-to-head trials, icotrokinra demonstrated superiority over deucravacitinib and showed strong results on difficult-to-treat areas like the scalp and genitals.
Across studies, patients taking icotrokinra experienced similar rates of adverse events compared to placebo, with no new safety concerns identified. The simplicity of a once-daily pill, combined with significant skin clearance and a favorable safety profile, underscores icotrokinra’s potential to shift the treatment paradigm for plaque psoriasis.
Read Announcement
TAR-210 FDA Regulatory Events
TAR-210 is a drug developed by Johnson & Johnson for the following indication: In Patients With High-Risk And Intermediate-Risk Non-Muscle-Invasive Bladder Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TAR-210
- Announced Date:
- March 13, 2026
- Indication:
- In Patients With High-Risk And Intermediate-Risk Non-Muscle-Invasive Bladder Cancer,
Announcement
Johnson & Johnson announced results from an open-label, multicenter Phase 1 study evaluating an investigational intravesical drug-releasing system with erdafitinib (Erda-iDRS) in patients with intermediate-risk and high-risk non–muscle-invasive bladder cancer (NMIBC) whose tumors harbor select fibroblast growth factor receptor (FGFR) alterations.
AI Summary
Johnson & Johnson reported results from an open-label, multicenter Phase 1 study of an investigational intravesical drug‑releasing system that delivers erdafitinib (Erda‑iDRS) to patients with intermediate‑ and high‑risk non–muscle‑invasive bladder cancer (NMIBC) whose tumors have selected FGFR alterations. The study tested a local delivery approach intended to target tumor cells in the bladder lining while limiting systemic exposure. The trial enrolled patients in both intermediate‑ and high‑risk groups and focused on those with qualifying FGFR changes.
In the high‑risk cohort, median recurrence‑free survival was 20 months (95% CI, 15–30), and the 12‑month recurrence‑free survival rate was 83% (95% CI, 62–93). With a median follow‑up of 24 months (range 15–30), about 31% of patients remained in follow‑up. Johnson & Johnson continues to develop Erda‑iDRS; Janssen previously licensed erdafitinib from Astex Pharmaceuticals to support such efforts.
Read Announcement
Darzalex Faspro FDA Regulatory Events
Darzalex Faspro is a drug developed by Johnson & Johnson for the following indication: newly diagnosed light chain amyloidosis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Darzalex Faspro
- Announced Date:
- March 6, 2026
- Indication:
- newly diagnosed light chain amyloidosis
Announcement
Halozyme Therapeutics, Inc. announced that Johnson & Johnson has received approval from the U.S. Food and Drug Administration (FDA) for TECVAYLI® (teclistamab-cqyv) in combination with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior line of therapy.1
AI Summary
Halozyme Therapeutics announced that Johnson & Johnson received FDA approval for TECVAYLI (teclistamab‑cqyv) in combination with DARZALEX FASPRO (daratumumab and hyaluronidase‑fihj) to treat adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. The approval was based on Phase 3 data showing statistically significant improvements in progression‑free survival and overall survival versus standard‑of‑care regimens.
Both TECVAYLI and DARZALEX FASPRO are administered subcutaneously, which allows use across different care settings. DARZALEX FASPRO incorporates Halozyme’s ENHANZE technology to enable this subcutaneous delivery. Halozyme’s CEO noted the new regimen offers an effective, more convenient option for patients with RRMM, potentially improving outcomes while simplifying treatment administration.Read Announcement
- Drug:
- Darzalex Faspro
- Announced Date:
- November 19, 2025
- Indication:
- newly diagnosed light chain amyloidosis
Announcement
johnson & Johnson announced that the Food and Drug Administration granted traditional approval to daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech Inc.) with bortezomib, cyclophosphamide, and dexamethasone (VCd) for newly diagnosed light chain (AL) amyloidosis.
Read Announcement
TECVAYLI FDA Regulatory Timeline and Events
TECVAYLI is a drug developed by Johnson & Johnson for the following indication: For patients with newly diagnosed multiple myeloma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TECVAYLI
- Announced Date:
- March 5, 2026
- Indication:
- For patients with newly diagnosed multiple myeloma
Announcement
Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) approved TECVAYLI® (teclistamab-cqyv) plus DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent.1
AI Summary
Johnson & Johnson announced that the U.S. Food and Drug Administration approved TECVAYLI® (teclistamab‑cqyv) plus DARZALEX FASPRO® (daratumumab and hyaluronidase‑fihj) for adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent. Tecvayli is a bispecific antibody that redirects a patient’s T cells to target BCMA on myeloma cells, while Darzalex Faspro combines daratumumab, an anti‑CD38 antibody, with hyaluronidase to allow subcutaneous dosing. The approval clears this targeted, immunotherapy‑based combination as a treatment option for patients earlier in their disease course after initial therapy, offering a non‑chemotherapy approach that pairs T‑cell engagement with anti‑CD38 activity. Clinicians will consider patient history, prior treatments, and tolerability when deciding if this regimen is appropriate.
Read Announcement- Drug:
- TECVAYLI
- Announced Date:
- January 14, 2026
- Indication:
- For patients with newly diagnosed multiple myeloma
Announcement
Johnson & Johnson announced positive topline results from the investigational Phase 3 MajesTEC-9 study of TECVAYLI® (teclistamab-cqyv) monotherapy, showing a 71% reduction in the risk of disease progression or death and a 40% reduction in the risk of death in a patient population that was predominantly refractory to anti-CD38 therapy and lenalidomide.
AI Summary
Johnson & Johnson reported positive topline results from the Phase 3 MajesTEC-9 study of TECVAYLI® (teclistamab-cqyv) monotherapy, showing a 71% reduction in the risk of disease progression or death (HR=0.29; 95% CI: 0.23–0.38) and a 40% reduction in the risk of death (HR=0.60; 95% CI: 0.43–0.83) versus standard of care. The results confirmed superior progression-free and overall survival with TECVAYLI® as early as second-line treatment.
MajesTEC-9 compared TECVAYLI® to investigator’s choice of PVd (pomalidomide, bortezomib, dexamethasone) or Kd (carfilzomib, dexamethasone) in patients with 1–3 prior lines of therapy. All participants had prior anti‑CD38 and lenalidomide exposure; most were refractory to anti‑CD38 (85%) and lenalidomide (79%), and over 90% were refractory to their last therapy.
The safety profile of TECVAYLI® monotherapy was described as clinically manageable and consistent with its known profile, with no new safety concerns identified. Topline findings were confirmed at the planned interim analysis and the independent data monitoring committee recommended unblinding; full results will be presented at a future medical meeting.
Read Announcement- Drug:
- TECVAYLI
- Announced Date:
- December 9, 2025
- Indication:
- For patients with newly diagnosed multiple myeloma
Announcement
Johnson & Johnson announced new data from the investigational Phase 3 MajesTEC-3 study that demonstrate the potential of TECVAYLI® (teclistamab-cqyv) plus DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) as early as second line for patients with relapsed/refractory multiple myeloma (RRMM).
AI Summary
Johnson & Johnson reported Phase 3 MajesTEC-3 results showing the investigational combination of TECVAYLI® (teclistamab‑cqyv) plus DARZALEX FASPRO® (daratumumab and hyaluronidase‑fihj) can be effective as early as second line for relapsed/refractory multiple myeloma. At nearly three years, the combo cut risk of progression or death by 83% versus standard regimens (HR 0.17; P<0.0001) and improved overall survival (HR 0.46), with 3‑year OS of 83.3% vs 65.0%. Response outcomes favored the combo: complete response ≥CR 81.8% vs 32.1%, overall response 89.0% vs 75.3%, and MRD‑negativity 58.4% vs 17.1%.
Safety was manageable but events were common: Grade 3/4 treatment‑emergent adverse events were similar between arms, infections and early cytokine release syndrome (60.1%, all Grade 1/2) were notable but were addressed with prophylaxis and established protocols. J&J has submitted a supplemental application and the regimen received Breakthrough Therapy Designation as regulatory review proceeds.
Read Announcement- Drug:
- TECVAYLI
- Announced Date:
- October 16, 2025
- Indication:
- For patients with newly diagnosed multiple myeloma
Announcement
Johnson & Johnson announced positive topline results from the investigational Phase 3 MajesTEC-3 study.
AI Summary
Johnson & Johnson announced positive topline results from the Phase 3 MajesTEC-3 study. The trial compared an investigational combination of TECVAYLI and DARZALEX FASPRO with standard regimens DPd or DVd in patients with relapsed or refractory multiple myeloma after one to three prior therapies.
At nearly three years of follow-up, the combination met the primary endpoint of progression-free survival and showed statistically significant improvement over standard care. The first interim analysis also revealed a significant benefit in overall survival. Based on these strong results, an independent data monitoring committee recommended unblinding the trial early.
These findings make MajesTEC-3 the first Phase 3 study to prove that combining TECVAYLI and DARZALEX FASPRO delivers better outcomes than current regimens in earlier lines of treatment. Johnson & Johnson plans to present full data at a major medical meeting and discuss the results with health authorities.
Read Announcement- Drug:
- TECVAYLI
- Announced Date:
- September 19, 2025
- Indication:
- For patients with newly diagnosed multiple myeloma
Announcement
Johnson & Johnson announced that an investigational immune-based induction regimen with TECVAYLI® (teclistamab-cqyv) and DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) demonstrated meaningful clinical efficacy in transplant-eligible (TE) patients with newly diagnosed multiple myeloma (NDMM).
AI Summary
Johnson & Johnson reported that a Phase 2 study of TECVAYLI® and DARZALEX FASPRO® showed meaningful efficacy in transplant-eligible patients with newly diagnosed multiple myeloma.
Forty-nine patients received induction regimens combining these drugs with lenalidomide, with or without bortezomib. After induction, all patients (100%) achieved at least a partial response, and all 46 evaluable patients were MRD-negative at 10⁻⁵ sensitivity. By sequencing, they were MRD-negative at 10⁻⁶ after six cycles. Overall, 85.7% reached complete response or better by Cycle 6. Additionally, 96% successfully collected stem cells.
The safety profile was manageable. The most common side effects were blood-related, and 36.7% experienced serious infections. No patients discontinued treatment, and all cytokine release syndrome cases were mild or moderate.
These findings support further study of this doublet immunotherapy earlier in the treatment journey.
Read Announcement- Drug:
- TECVAYLI
- Announced Date:
- December 8, 2024
- Indication:
- For patients with newly diagnosed multiple myeloma
Announcement
Johnson & Johnson announced new frontline data featuring TECVAYLI® (teclistamab-cqyv) from two investigational studies in patients with newly diagnosed multiple myeloma (NDMM) in induction and maintenance settings.
AI Summary
Johnson & Johnson announced new frontline data on TECVAYLI® (teclistamab-cqyv) from two investigational studies in patients with newly diagnosed multiple myeloma (NDMM). The studies evaluated TECVAYLI in both induction and maintenance settings. Early findings indicate that TECVAYLI, when added to standard treatment regimens, may enhance response rates and improve progression-free survival for NDMM patients. In the induction phase, the investigational study focused on how TECVAYLI could help achieve a deeper response early in treatment. In the maintenance phase, the data suggested that continued therapy with TECVAYLI might sustain treatment benefits over time. Johnson & Johnson’s announcement highlights the potential of TECVAYLI to offer a new treatment option for NDMM patients, aiming to improve long-term outcomes and provide additional hope for those facing this challenging blood cancer.
Read Announcement
Nipocalimab FDA Regulatory Timeline and Events
Nipocalimab is a drug developed by Johnson & Johnson for the following indication: Treatment of alloimmunisedc pregnant individuals at high risk of severe HDFN.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Nipocalimab
- Announced Date:
- March 3, 2026
- Indication:
- Treatment of alloimmunisedc pregnant individuals at high risk of severe HDFN
Announcement
Johnson & Johnson announced that nipocalimaba was granted U.S. Food and Drug Administration (FDA) Fast Track designation as a potential treatment for adults with systemic lupus erythematosus (SLE), a debilitating autoantibody-driven disease that impacts approximately 3 to 5 million people worldwide.1
AI Summary
Johnson & Johnson announced that nipocalimab received U.S. Food and Drug Administration Fast Track designation as a potential treatment for adults with systemic lupus erythematosus (SLE). The Fast Track status reflects the unmet need in this serious disease and can enable a faster, more flexible review process that might speed patient access if later trials confirm benefit.
The designation is supported by Phase 2 results showing nipocalimab reduced lupus disease activity and suggested potential for steroid-sparing effects. SLE is a chronic, autoantibody-driven disease that affects multiple organs, has limited treatment options, and can lead to irreversible organ damage. It impacts an estimated 3 to 5 million people worldwide.
Johnson & Johnson is actively enrolling adults with active SLE in a Phase 3 study to further evaluate nipocalimab. Nipocalimab is not approved for SLE; its safety and effectiveness remain under investigation.Read Announcement
- Drug:
- Nipocalimab
- Announced Date:
- January 6, 2026
- Indication:
- Treatment of alloimmunisedc pregnant individuals at high risk of severe HDFN
Announcement
Johnson & Johnson announced positive topline results from the Phase 2b JASMINE (NCT04882878) study of adults living with systemic lupus erythematosus (SLE) and the initiation of a Phase 3 program.
AI Summary
Johnson & Johnson announced positive topline results from the Phase 2b JASMINE (NCT04882878) study of nipocalimab in adults with systemic lupus erythematosus (SLE). The trial met its primary endpoint—statistically significant improvement on the SLE Responder Index (SRI‑4) at Week 24 versus placebo—and also met key secondary and exploratory endpoints, including signals that nipocalimab may allow patients to reduce steroid use. Safety and tolerability were consistent with earlier Phase 2 studies, with no new safety concerns reported.
JASMINE was a 52‑week, multicenter, randomized, double‑blind, placebo‑controlled, dose‑ranging study of 228 adults with active SLE. These results represent the first positive study of an FcRn blocker in active SLE.
Based on the positive topline data, Johnson & Johnson plans to initiate a Phase 3 program for nipocalimab to further study its impact on disease activity and steroid sparing. SLE is an autoantibody‑driven disease that can cause wide‑ranging organ damage and reduced quality of life.
Read Announcement- Drug:
- Nipocalimab
- Announced Date:
- August 28, 2025
- Indication:
- Treatment of alloimmunisedc pregnant individuals at high risk of severe HDFN
Announcement
Johnson & Johnson shared topline data from the Phase 2a DAISY proof-of-concept study evaluating the combination of nipocalimab with an anti-tumor necrosis factor alpha (anti-TNFα) therapy in rheumatoid arthritis (RA) patients with refractory disease.
Read Announcement- Drug:
- Nipocalimab
- Announced Date:
- March 26, 2025
- Indication:
- Treatment of alloimmunisedc pregnant individuals at high risk of severe HDFN
Announcement
Johnson & Johnson announced today that 12 abstracts, including two oral presentations, highlighting the Company's innovative autoantibody disease research and the potential of nipocalimab to provide long-term sustained disease control in the treatment of generalized myasthenia gravis (gMG), will be presented at the 2025 American Academy of Neurology (AAN) Annual Meeting from April 5 – 9 in San Diego, California.
AI Summary
Johnson & Johnson announced that 12 abstracts, including two oral presentations, will be showcased at the 2025 American Academy of Neurology (AAN) Annual Meeting in San Diego from April 5–9. The presentations highlight the company’s advanced research on autoantibody diseases and the potential of nipocalimab for long-term disease control in patients with generalized myasthenia gravis (gMG).
One oral presentation features encouraging new data from the 24‐week pivotal Vivacity-MG3 study. The results, measured by the clinician-assessed QMGa score, demonstrate that nipocalimab can provide sustained disease control in adult patients who are positive for key antibodies. These findings underline nipocalimab’s promise as an innovative treatment option for gMG, potentially improving patient outcomes over the long term.
Read Announcement- Drug:
- Nipocalimab
- Announced Date:
- March 18, 2025
- Indication:
- Treatment of alloimmunisedc pregnant individuals at high risk of severe HDFN
Announcement
Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has granted investigational nipocalimab Fast Track designation (FTD) for the treatment of adult patients with moderate-to-severe Sjögren's disease (SjD), having previously been granted Breakthrough Therapy designation (BTD) for the investigational therapy late last year.
AI Summary
Johnson & Johnson announced in March 2025 that the FDA has granted investigational nipocalimab Fast Track designation for the treatment of adult patients with moderate-to-severe Sjögren's disease. This designation aims to accelerate the development and review process, potentially bringing new treatment options sooner to patients who currently have no advanced therapies approved. The Fast Track status highlights the urgent need for effective treatments as Sjögren's disease is a debilitating condition that causes symptoms such as chronic dryness, joint pain, and fatigue, severely impacting quality of life. Johnson & Johnson is actively enrolling patients in the Phase 3 DAFFODIL study to further assess the safety and effectiveness of nipocalimab, signaling a promising step forward in addressing the unmet medical needs of those living with this challenging autoimmune disease.
Read Announcement- Drug:
- Nipocalimab
- Announced Date:
- February 13, 2025
- Indication:
- Treatment of alloimmunisedc pregnant individuals at high risk of severe HDFN
Announcement
Johnson & Johnson announced the publication of data detailing the differentiated molecular properties of nipocalimab, an investigational neonatal Fc receptor (FcRn) blocker, in mAbs.a
AI Summary
Johnson & Johnson recently published new data on nipocalimab in the journal mAbs. Nipocalimab is an investigational neonatal Fc receptor (FcRn) blocker that binds to FcRn with high, pH-independent affinity. This binding reduces circulating IgG levels by more than 75%, including harmful autoantibodies, without interfering with other immune functions. The data highlight the antibody’s selective and targeted properties, supporting its potential as a treatment for diseases driven by IgG autoantibodies and alloantibodies. Preclinical studies confirmed that nipocalimab can block IgG recycling, thereby effectively lowering IgG levels in a time- and dose-dependent manner. These unique molecular characteristics could offer a promising treatment option for patients suffering from conditions linked to autoantibody production, suggesting further exploration of nipocalimab’s use in clinical settings.
Read Announcement- Drug:
- Nipocalimab
- Announced Date:
- January 23, 2025
- Indication:
- Treatment of alloimmunisedc pregnant individuals at high risk of severe HDFN
Announcement
Johnson & Johnson announced The Lancet Neurology has published results from the pivotal Phase 3 study of nipocalimab, an investigational FcRn blocker, evaluated in a broad population of antibody positive (anti-AChR+, anti-MuSK+, anti-LRP4+) adults with generalized myasthenia gravis (gMG).1
AI Summary
Johnson & Johnson announced that The Lancet Neurology recently published promising Phase 3 study results for nipocalimab, an investigational FcRn blocker. The study, called Vivacity-MG3, evaluated nipocalimab in a broad group of antibody positive adults with generalized myasthenia gravis (gMG), including patients with anti-AChR+, anti-MuSK+, and anti-LRP4+ antibodies. Results showed that nipocalimab provided sustained disease control over 24 weeks and reduced autoantibody levels by up to 75%, addressing one of the root causes of gMG. The study found statistically significant and clinically meaningful improvements in daily functioning, while the drug maintained a safety profile similar to placebo. These findings suggest that nipocalimab has the potential to become a valuable treatment option for a wide range of gMG patients, offering long-term improvement and safety in managing this debilitating condition.
Read Announcement- Drug:
- Nipocalimab
- Announced Date:
- January 9, 2025
- Indication:
- Treatment of alloimmunisedc pregnant individuals at high risk of severe HDFN
Announcement
Johnson & Johnson announced the nipocalimab Biologics License Application (BLA) received Priority Review designation from the U.S Food and Drug Administration (FDA) for the treatment of antibody positive (anti-AChR, anti-MuSK, anti-LRP4) patients with generalized myasthenia gravis (gMG), as supported by findings from the Phase 3 Vivacity-MG3 study.
AI Summary
Johnson & Johnson announced that its nipocalimab Biologics License Application (BLA) has received Priority Review from the U.S. FDA for treating generalized myasthenia gravis (gMG) in patients who test positive for antibodies such as anti-AChR, anti-MuSK, and anti-LRP4. This FDA designation means that the agency will speed up the review process for this treatment because it could offer significant improvements over existing options.
The Priority Review decision is supported by strong results from the Phase 3 Vivacity-MG3 study, which demonstrated sustained disease control over 24 weeks in a broad group of antibody-positive adult patients. Johnson & Johnson is collaborating closely with the FDA, aiming to bring nipocalimab to those living with gMG and addressing a critical need for more effective treatment options.
Read Announcement- Drug:
- Nipocalimab
- Announced Date:
- August 29, 2024
- Indication:
- Treatment of alloimmunisedc pregnant individuals at high risk of severe HDFN
Announcement
Johnson & Johnson announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking the first approval of nipocalimab globally for the treatment of people living with generalized myasthenia gravis (gMG).
AI Summary
Johnson & Johnson has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking the first global approval for nipocalimab as a treatment for generalized myasthenia gravis (gMG). Nipocalimab is an investigational monoclonal antibody designed to block the FcRn receptor, thereby lowering harmful autoantibodies that contribute to gMG symptoms. This submission is backed by positive data from the Phase 3 Vivacity-MG3 study, which showed that patients receiving nipocalimab in addition to standard care experienced sustained symptom improvement over 24 weeks. The study demonstrated that a broad range of antibody-positive gMG patients had better disease control compared to those on standard care with a placebo. Johnson & Johnson is optimistic about this advancement and looks forward to the FDA’s review of the supporting data.
Read Announcement
Pasritamig FDA Regulatory Events
Pasritamig is a drug developed by Johnson & Johnson for the following indication: in advanced prostate cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- pasritamig
- Announced Date:
- February 26, 2026
- Indication:
- in advanced prostate cancer
Announcement
Johnson & Johnson announced preliminary results from a Phase 1b study evaluating pasritamig (JNJ-78278343), a first-in-class bispecific T-cell engaging antibody, in combination with docetaxel in patients with metastatic castration-resistant prostate cancer.
AI Summary
Johnson & Johnson announced preliminary Phase 1b results for pasritamig (JNJ-78278343), a first-in-class bispecific T‑cell engaging antibody, given with docetaxel to patients with metastatic castration‑resistant prostate cancer (mCRPC). The company reported the combination produced deep PSA responses, indicating strong anti‑tumor activity in many participants.
Investigators also observed a favorable safety profile for the combination, with side effects described as manageable in the study population. Johnson & Johnson said these results highlight the potential of this next‑generation T‑cell engager to broaden the role of immunotherapy in prostate cancer, a disease where immune approaches have been limited.
Based on the encouraging early data, the company plans to advance the program into a Phase 3 trial to confirm benefits and further evaluate safety. These findings are preliminary and require confirmatory, larger studies before changing clinical practice.
Read Announcement
RYBREVANT FASPRO™ FDA Regulatory Timeline and Events
RYBREVANT FASPRO™ is a drug developed by Johnson & Johnson for the following indication: for patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- RYBREVANT FASPRO™
- Announced Date:
- February 19, 2026
- Indication:
- for patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer
Announcement
Johnson & Johnson announced new results from the Phase 1b/2 OrigAMI-4 study showing that first-line treatment with investigational subcutaneous amivantamab and hyaluronidase-lpuj in combination with a PD-1 inhibitor delivered clinically meaningful and durable antitumor activity in patients with head and neck squamous cell carcinoma (HNSCC) that is recurrent or metastatic, PD-L1-positive, and human papillomavirus (HPV)-unrelated. Data were presented during a plenary session at the 2026
AI Summary
Johnson & Johnson reported new Phase 1b/2 OrigAMI-4 results showing that first-line treatment with investigational subcutaneous amivantamab plus hyaluronidase-lpuj, given with a PD‑1 inhibitor, produced clinically meaningful and durable antitumor activity in patients with recurrent or metastatic, PD‑L1‑positive, HPV‑unrelated head and neck squamous cell carcinoma (HNSCC).
The company highlighted a 10% complete response rate and rapid onset of durable responses. RYBREVANT FASPRO™ (amivantamab and hyaluronidase‑lpuj) was dosed weekly during the initial period, then every three weeks with weight‑based adjustments; the primary endpoint was overall response rate assessed by blinded independent central review using RECIST v1.1. Johnson & Johnson stated the results surpass current standards of care.
These data were presented in a plenary session at the 2026 Multidisciplinary Head and Neck Cancers Symposium. The regimen remains investigational and further study will determine its place in treatment.Read Announcement
- Drug:
- RYBREVANT FASPRO™
- Announced Date:
- February 18, 2026
- Indication:
- for patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer
Announcement
Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for subcutaneous amivantamab and hyaluronidase-lpuj as a monotherapy for the treatment of adults with head and neck squamous cell carcinoma that is recurrent or metastatic and human papillomavirus (HPV)-unrelated after disease progression on or after platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor.
AI Summary
Johnson & Johnson announced the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation (BTD) for subcutaneous amivantamab plus hyaluronidase‑lpuj as a single‑agent treatment for adults with recurrent or metastatic, HPV‑unrelated head and neck squamous cell carcinoma whose disease progressed on or after platinum‑based chemotherapy and a PD‑1 or PD‑L1 inhibitor. The decision was based on early clinical data showing rapid and durable tumor responses in a heavily pretreated patient group, suggesting the therapy may offer meaningful benefits where few options exist.
BTD is intended to speed development and review of drugs that show substantial improvement over available treatments on important clinical measures. This designation could accelerate further trials and regulatory review, and it signals a potential expansion of the drug’s promise beyond its initial use in lung cancer. Ongoing studies will determine safety and long‑term benefit for this patient population.
Read Announcement- Drug:
- RYBREVANT FASPRO™
- Announced Date:
- February 17, 2026
- Indication:
- for patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer
Announcement
Johnson & Johnson announced the U.S. Food and Drug Administration (FDA) has approved a new, simplified monthly dosing schedule* for RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj).
AI Summary
Johnson & Johnson announced the U.S. Food and Drug Administration has approved a new, simplified monthly dosing schedule for RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj). The change is meant to reduce treatment visits while maintaining the medicine’s established safety and effectiveness. The company says the new schedule supports delivering a simpler, faster combination regimen for patients with EGFR‑positive non‑small cell lung cancer. RYBREVANT FASPRO is co‑formulated with recombinant human hyaluronidase PH20 using Halozyme’s ENHANZE drug delivery technology to enable subcutaneous dosing.
No new safety signals were identified in the data. Only 8% of patients stopped amivantamab because of treatment‑related side effects. Mean plasma drug levels matched historical intravenous and twice‑monthly subcutaneous dosing, supporting pharmacokinetic comparability. The approved schedule begins once‑monthly dosing at week 5, with weekly injections during weeks 1–4, aiming to lower clinic visits while keeping the known benefit and safety profile.
Read Announcement- Drug:
- RYBREVANT FASPRO™
- Announced Date:
- December 17, 2025
- Indication:
- for patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer
Announcement
Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) approved RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj), the first and only subcutaneously (SC) administered therapy for patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).
AI Summary
Johnson & Johnson announced that the U.S. Food and Drug Administration approved RYBREVANT FASPRO™ (amivantamab and hyaluronidase‑lpuj), the first and only subcutaneously delivered therapy for patients with EGFR‑mutated non‑small cell lung cancer (NSCLC). The formulation enables a quick five‑minute injection instead of multi‑hour intravenous infusions and is approved across the same indications as RYBREVANT®.
Clinical data from the Phase 3 PALOMA‑3 study showed that the subcutaneous version achieves consistent drug levels versus IV delivery while improving patient experience and outcomes. Compared with IV amivantamab, RYBREVANT FASPRO™ had about a fivefold lower rate of administration‑related reactions (13% vs 66%), a lower overall venous thromboembolism rate (11% vs 18%), and showed longer duration of response, better progression‑free survival, and higher 12‑month survival (65% SC vs 51% IV).
The safety profile was largely consistent with IV amivantamab. Johnson & Johnson also offers patient support resources to help with access and treatment management.Read Announcement
DARZALEX FASPRO-VRd FDA Regulatory Events
DARZALEX FASPRO-VRd is a drug developed by Johnson & Johnson for the following indication: for newly diagnosed multiple myeloma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- DARZALEX FASPRO-VRd
- Announced Date:
- January 27, 2026
- Indication:
- for newly diagnosed multiple myeloma
Announcement
johnson & Johnson announced that the Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for adults with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).
Read Announcement
TRUFILL n‑BCA FDA Regulatory Events
TRUFILL n‑BCA is a drug developed by Johnson & Johnson for the following indication: Symptomatic Chronic Subdural Hematoma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TRUFILL n‑BCA
- Announced Date:
- December 18, 2025
- Indication:
- Symptomatic Chronic Subdural Hematoma
Announcement
Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for the TRUFILL n‑BCA Liquid Embolic System for embolization of the middle meningeal artery (MMA) for the treatment of symptomatic subacute and chronic Subdural Hematoma (cSDH) as an adjunct to surgery.
AI Summary
Johnson & Johnson MedTech announced that the U.S. Food and Drug Administration has approved an expanded indication for the TRUFILL n‑BCA Liquid Embolic System to embolize the middle meningeal artery (MMA) for treatment of symptomatic subacute and chronic subdural hematoma (cSDH) as an adjunct to surgery.
cSDH often follows minor head trauma and is more common in older adults and people on blood thinners. While surgery is the usual treatment, recurrence rates are reported at about 10–20%. Embolization of the MMA is a minimally invasive endovascular approach that targets smaller vessels thought to feed the hematoma and reduce regrowth. The approval was supported by the randomized MEMBRANE trial, which found TRUFILL n‑BCA more effective than standard care for MMA embolization in symptomatic cSDH and showed an acceptable safety profile.
TRUFILL n‑BCA has been a trusted neurovascular embolization tool for over 25 years, and this expanded indication adds a non‑surgical option to help manage cSDH and lower recurrence risk for some patients.
Read Announcement
DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) + Pomalidomide + Dexamethasone FDA Regulatory Timeline and Events
DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) + Pomalidomide + Dexamethasone is a drug developed by Johnson & Johnson for the following indication: Multiple Myeloma After First / Subsequent Relapse.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) + Pomalidomide + Dexamethasone
- Announced Date:
- November 7, 2025
- Indication:
- Multiple Myeloma After First / Subsequent Relapse
Announcement
Halozyme Therapeutics, Inc. announced that Johnson & Johnson received U.S. Food and Drug Administration (FDA) approval of a new indication for DARZALEX Faspro® (daratumumab and hyaluronidase-fihj) co-formulated with ENHANZE®, as single agent treatment of adult patients with high-risk smoldering multiple myeloma (HR-SMM).
AI Summary
Johnson & Johnson received U.S. FDA approval for a new indication of DARZALEX Faspro (daratumumab and hyaluronidase‑fihj) co‑formulated with Halozyme’s ENHANZE as a single‑agent treatment for adult patients with high‑risk smoldering multiple myeloma (HR‑SMM). This makes DARZALEX Faspro the first and only approved therapy for HR‑SMM, allowing earlier treatment before progression to active multiple myeloma. Halozyme said the approval expands DARZALEX Faspro’s use and reinforces its role across disease stages.
The FDA decision was based on the AQUILA Phase 3 trial, which compared DARZALEX Faspro to active monitoring (“watch and wait”) in patients with HR‑SMM and was the largest Phase 3 study in this group. HR‑SMM is asymptomatic but high risk; about half of patients with HR‑SMM are likely to progress to active disease within two years. ENHANZE enables subcutaneous delivery to improve patient experience and lower treatment burden.
Read Announcement- Drug:
- DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) + Pomalidomide + Dexamethasone
- Announced Date:
- November 6, 2025
- Indication:
- Multiple Myeloma After First / Subsequent Relapse
Announcement
Johnson & Johnson announced that the Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) for adults with high-risk smoldering multiple myeloma (SMM).
Read Announcement- Drug:
- DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) + Pomalidomide + Dexamethasone
- Announced Date:
- June 3, 2025
- Indication:
- Multiple Myeloma After First / Subsequent Relapse
Announcement
Johnson & Johnson announced data from two studies highlighting that a DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based quadruplet regimen demonstrated deep and sustained minimal residual disease (MRD) negativity rates, and improved long-term progression-free survival (PFS) in patients with newly diagnosed multiple myeloma (NDMM), regardless of transplant status.1,2,3 Findings were highlighted as oral presentations of an analysis of sustained MRD in transplant-eligible patients from the Phase 3 PERSEUS study (Abstract #7501) and a subgroup analysis of transplant-ineligible patients in the Phase 3 CEPHEUS study (Abstract #7516) at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.
AI Summary
Johnson & Johnson recently announced encouraging data from two studies on its DARZALEX FASPRO®‐based quadruplet regimen for patients newly diagnosed with multiple myeloma (NDMM). The regimen demonstrated deep and sustained minimal residual disease (MRD) negativity rates, which is seen as a crucial indicator of effective treatment. Additionally, it improved long‐term progression-free survival (PFS) in patients regardless of whether they were eligible for a transplant, suggesting the treatment may offer broad benefits.
The findings were presented as oral presentations at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. Specifically, the data from transplant-eligible patients came from an analysis in the Phase 3 PERSEUS study (Abstract #7501), while additional insights from transplant-ineligible patients were shared from a subgroup analysis in the Phase 3 CEPHEUS study (Abstract #7516). These results underline the potential of the regimen as a promising option for NDMM treatment.
Read Announcement- Drug:
- DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) + Pomalidomide + Dexamethasone
- Announced Date:
- May 20, 2025
- Indication:
- Multiple Myeloma After First / Subsequent Relapse
Announcement
Johnson & Johnson announced the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted (6-2) in favor of the benefit-risk profile of single-agent DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for the treatment of adult patients with high-risk smoldering multiple myeloma (HR-SMM). An application for the approval of DARZALEX FASPRO® for adult patients with HR-SMM was submitted to the FDA in November 2024.
AI Summary
Johnson & Johnson announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 6-2 in favor of the benefit-risk profile of single-agent DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for treating adult patients with high-risk smoldering multiple myeloma (HR-SMM). This recommendation was based on positive findings from the Phase 3 AQUILA study, which showed significant improvements in progression-free survival and clinical outcomes. An application for approval was submitted to the FDA in November 2024. If approved, DARZALEX FASPRO® would become the first treatment option aimed at delaying or potentially preventing the progression of HR-SMM to active multiple myeloma, offering a proactive alternative to the current “watch and wait” approach for these patients.
Read Announcement- Drug:
- DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) + Pomalidomide + Dexamethasone
- Announced Date:
- December 8, 2024
- Indication:
- Multiple Myeloma After First / Subsequent Relapse
Announcement
Johnson & Johnson announced data from the Phase 3 AQUILA study showing that DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) significantly delayed progression from high-risk smoldering multiple myeloma (SMM) to active multiple myeloma (MM) and extended overall survival compared to the current standard of care of active monitoring.1
AI Summary
Johnson & Johnson announced promising results from the Phase 3 AQUILA study. The study showed that DARZALEX FASPRO® significantly delayed the progression from high-risk smoldering multiple myeloma (SMM) to active multiple myeloma (MM) and improved overall survival compared to the current standard of care, which relies on active monitoring.
These findings suggest that early intervention with DARZALEX FASPRO® may help patients avoid more aggressive treatments later on. Clinicians and regulatory experts are optimistic that this innovative subcutaneous therapy can provide a meaningful benefit by extending the time before the disease advances and by improving survival outcomes. Future studies are expected to further explore its long-term benefits and potential applications in treating multiple myeloma.
Read Announcement- Drug:
- DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) + Pomalidomide + Dexamethasone
- Announced Date:
- September 30, 2024
- Indication:
- Multiple Myeloma After First / Subsequent Relapse
Announcement
Johnson & Johnson announced today the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for approval of a new indication for DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone (D-VRd) for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) for whom autologous stem cell transplant (ASCT) is deferred or who are ineligible for ASCT.
AI Summary
Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. FDA for DARZALEX FASPRO® when used in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd). This new indication is aimed at treating adult patients with newly diagnosed multiple myeloma (NDMM) who either defer autologous stem cell transplant (ASCT) or cannot undergo the procedure. The application is supported by data from the Phase 3 CEPHEUS study, which showed that 60.9% of patients receiving D-VRd achieved minimal residual disease (MRD) negativity. The study also demonstrated a 43% reduction in the risk of disease progression or death compared to the standard treatment, highlighting the potential of this quadruplet regimen as a treatment option regardless of transplant eligibility.
Read Announcement- Drug:
- DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) + Pomalidomide + Dexamethasone
- Announced Date:
- September 27, 2024
- Indication:
- Multiple Myeloma After First / Subsequent Relapse
Announcement
Johnson & Johnson announced today results from the Phase 3 CEPHEUS study demonstrating a significant clinical improvement with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone (D-VRd) in the treatment of patients with newly diagnosed multiple myeloma (NDMM) who are transplant ineligible (TIE) or for whom transplant was not planned as initial therapy (transplant deferred).
AI Summary
Johnson & Johnson announced promising results from the Phase 3 CEPHEUS study, which evaluated DARZALEX FASPRO® (a combination of daratumumab and hyaluronidase-fihj) when paired with bortezomib, lenalidomide, and dexamethasone (D-VRd) for newly diagnosed multiple myeloma patients. The study focused on patients who were either not eligible for transplant or had chosen to delay it. The findings showed a significant clinical improvement in these patients, indicating that the D-VRd regimen can lead to better treatment outcomes. This is encouraging news, as it offers a more effective treatment option for patients who cannot undergo a transplant or prefer to avoid it initially. The results support the potential of DARZALEX FASPRO® to improve quality of life and provide a strong alternative for managing multiple myeloma in this patient group.
Read Announcement- Drug:
- DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) + Pomalidomide + Dexamethasone
- Announced Date:
- July 30, 2024
- Indication:
- Multiple Myeloma After First / Subsequent Relapse
Announcement
Johnson & Johnson announced that that the U.S. Food and Drug Administration (FDA) approved DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone (D-VRd) for induction and consolidation in patients with newly diagnosed multiple myeloma (NDMM) who are eligible for an autologous stem cell transplant (ASCT).1
AI Summary
Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) for patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplants (ASCT). This combination is used during both the induction and consolidation phases of treatment, offering a new frontline option at the time of diagnosis.
Clinical studies supported this approval, showing that the D-VRd regimen reduced the risk of disease progression or death by 60 percent compared to prior treatments. These findings suggest that the quadruplet therapy can achieve deeper responses and prolong remissions, marking a significant step forward in the treatment of multiple myeloma for transplant-eligible patients.
Read Announcement
CAPLYTA (Lumateperone) FDA Regulatory Timeline and Events
CAPLYTA (Lumateperone) is a drug developed by Johnson & Johnson for the following indication: Depressive Episodes associated with Bipolar.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CAPLYTA (Lumateperone)
- Announced Date:
- November 6, 2025
- Indication:
- Depressive Episodes associated with Bipolar
Announcement
Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) approved CAPLYTA® (lumateperone) as an adjunctive therapy with antidepressants for the treatment of major depressive disorder (MDD) in adults.
AI Summary
Johnson & Johnson announced today that the U.S. Food and Drug Administration approved CAPLYTA® (lumateperone) as an adjunctive therapy with antidepressants for the treatment of major depressive disorder (MDD) in adults. This approval introduces a new, safe, and effective option that requires no dose titration, making it easy for patients to start and stay on therapy. CAPLYTA® showed a side-effect profile similar to placebo, with no notable increases in weight gain, metabolic changes, or sexual dysfunction.
In two Phase 3 trials, adding CAPLYTA® to an oral antidepressant produced significant improvements in depressive symptoms by six weeks, with clear separation from placebo as early as one to two weeks. A six-month open-label extension study demonstrated that 80 percent of patients responded to treatment and 65 percent achieved remission, highlighting its potential for lasting benefit.
Since about two-thirds of people with MDD experience residual symptoms despite standard antidepressants, CAPLYTA® offers an important new option to help more adults reach meaningful remission and improve overall quality of life.
Read Announcement- Drug:
- CAPLYTA (Lumateperone)
- Announced Date:
- October 10, 2025
- Indication:
- Depressive Episodes associated with Bipolar
Announcement
Johnson & Johnson announced that 17 abstracts featuring new clinical and real-world data will be presented at the annual European College of Neuropsychopharmacology (ECNP) Congress, taking place October 11-14 in Amsterdam, The Netherlands.
AI Summary
Johnson & Johnson announced that 17 abstracts featuring new clinical and real-world data will be presented at ECNP Congress, taking place October 11–14 in Amsterdam. A new post-hoc analysis of CAPLYTA® Phase 3 data evaluates its impact on sexual function in major depressive disorder, reinforcing its potential to reset treatment expectations. EU and UK subgroup analyses of Phase 3 data compare adjunctive seltorexant with quetiapine XR in patients with MDD and insomnia symptoms. Post-hoc findings from the ESCAPE-TRD study explore patient characteristics linked to remission with SPRAVATO® versus quetiapine XR.
Real-world safety data from the French ELLIPSE SPRAVATO study will also be shared. An expert Delphi study will outline consensus on key factors for continuing SPRAVATO in treatment-resistant depression. These presentations underscore Johnson & Johnson’s commitment to advancing innovative, patient-first therapies. They highlight diverse approaches to improving outcomes for people living with MDD or TRD.
Read Announcement- Drug:
- CAPLYTA (Lumateperone)
- Announced Date:
- July 8, 2025
- Indication:
- Depressive Episodes associated with Bipolar
Announcement
Johnson & Johnson announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) based upon long-term data evaluating the safety and efficacy of CAPLYTA® (lumateperone) for the prevention of relapse in schizophrenia.
AI Summary
Johnson & Johnson has submitted a supplemental New Drug Application (sNDA) to the U.S. FDA for CAPLYTA® (lumateperone) based on long-term Phase 3 data. The data show that CAPLYTA® significantly reduces the risk of relapse in adults with schizophrenia by 63% compared to placebo. In a double-blind, randomized withdrawal trial, patients receiving CAPLYTA® experienced a longer time before relapse, indicating improved long-term stability and reduced risk of hospitalizations. The study further demonstrated a delay in overall treatment discontinuation, and no new safety concerns were noted. This submission highlights CAPLYTA®’s potential to help prevent debilitating relapses, providing more treatment stability for individuals with schizophrenia. With this move, Johnson & Johnson continues to offer a broad range of treatment options, aiming to improve quality of life for patients and their families.
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INLEXZO FDA Regulatory Events
INLEXZO is a drug developed by Johnson & Johnson for the following indication: In Treating Muscle Invasive Bladder Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- INLEXZO
- Announced Date:
- October 20, 2025
- Indication:
- In Treating Muscle Invasive Bladder Cancer
Announcement
Johnson & Johnso announced that new data from the primary analysis of the ongoing Phase 2b SunRISe-4 study demonstrated that treatment with INLEXZO™ (gemcitabine intravesical system) plus intravenous (IV) cetrelimab (CET) before radical cystectomy resulted in a clinically meaningful rate of pathologic complete response (pCR) and pathologic overall response (pOR) in patients with muscle invasive bladder cancer (MIBC) who are ineligible for or refuse neoadjuvant platinum-based chemotherapy and are scheduled for bladder removal.
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Apalutamide FDA Regulatory Events
Apalutamide is a drug developed by Johnson & Johnson for the following indication: For the treatment of prostate cancer (nmCRPC).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- apalutamide
- Announced Date:
- October 7, 2025
- Indication:
- For the treatment of prostate cancer (nmCRPC)
Announcement
Kairos Pharma, Ltd. announced that it has been selected to present at the European Society for Medical Oncology (ESMO) Congress.
Read Announcement- Drug:
- apalutamide
- Announced Date:
- October 2, 2024
- Indication:
- For the treatment of prostate cancer (nmCRPC)
Announcement
Johnson & Johnson announced the results of a landmark real-world, head-to-head study showing that ERLEADA® (apalutamide) provided a statistically significant overall survival benefit at 24 months compared to enzalutamide in patients with metastatic castration-sensitive prostate cancer (mCSPC).
AI Summary
Johnson & Johnson announced a landmark real-world study comparing ERLEADA® (apalutamide) and enzalutamide for patients with metastatic castration-sensitive prostate cancer (mCSPC). The study, which followed FDA real-world evidence guidelines, analyzed nearly 4,000 patients who began treatment between December 2018 and December 2023. Results showed that patients starting on ERLEADA® experienced a statistically significant 23% reduction in the risk of death at 24 months compared to those on enzalutamide. The survival benefit with ERLEADA® is consistent with previous clinical trial findings, supporting its effectiveness as a once-daily, patient-friendly treatment option. These insights may help healthcare providers make better-informed decisions when choosing between androgen receptor pathway inhibitors in the management of mCSPC.
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ACUVUE OASYS MAX 1-Day FDA Regulatory Events
ACUVUE OASYS MAX 1-Day is a drug developed by Johnson & Johnson for the following indication: for Astigmatism.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ACUVUE OASYS MAX 1-Day
- Announced Date:
- October 7, 2025
- Indication:
- for Astigmatism
Announcement
Johnson & Johnson announced new data on the ACUVUE OASYS MAX 1-Day for ASTIGMATISM contact lenses which showed higher end-of-day comfort^ as compared to Dailies Total1® for Astigmatism.
AI Summary
At the American Academy of Optometry’s annual meeting in Boston, Johnson & Johnson announced new clinical data on ACUVUE OASYS MAX 1-Day for ASTIGMATISM contact lenses. In a head-to-head comparison against Dailies Total1® for Astigmatism, ACUVUE OASYS MAX achieved 70.4% end-of-day comfort versus 40.6% for its competitor, based on patient-reported adjusted top-2-box scores. Overall, 62% of wearers preferred ACUVUE OASYS MAX 1-Day for ASTIGMATISM for vision compared to only 18% who chose Dailies Total1®.
When evaluating performance on computer screens and other digital devices, 65% of patients favored ACUVUE OASYS MAX 1-Day for ASTIGMATISM versus 16% for Dailies Total1®. Johnson & Johnson credits these results to TearStable Technology, an OptiBlue Light Filter, and its BLINK STABILIZED Design, which help the lens stay aligned and comfortable throughout the day.
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RYBREVANT (amivantamab-vmjw) FDA Regulatory Timeline and Events
RYBREVANT (amivantamab-vmjw) is a drug developed by Johnson & Johnson for the following indication: Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations.
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- RYBREVANT (amivantamab-vmjw)
- Announced Date:
- September 7, 2025
- Indication:
- Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
Announcement
Johnson & Johnson announced The New England Journal of Medicine (NEJM) published results from the Phase 3 MARIPOSA study, which showed RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE® (lazertinib) demonstrated a statistically significant and clinically meaningful overall survival (OS) improvement for patients with previously untreated (first-line) locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations.1
AI Summary
Johnson & Johnson announced that The New England Journal of Medicine published results from the Phase 3 MARIPOSA study showing that RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE® (lazertinib) significantly improved overall survival (OS) in patients with untreated, locally advanced or metastatic non-small cell lung cancer (NSCLC) carrying EGFR exon 19 deletions or L858R mutations. At a median follow-up of 37.8 months, the combination reduced the risk of death by 25 percent compared to the standard TKI osimertinib (hazard ratio 0.75; P=0.005). Median OS for the combination has not been reached and is projected to exceed four years—over one year longer than the three-year median seen with osimertinib.
This chemotherapy-free regimen works by targeting EGFR and MET pathways and engaging the immune system. The safety profile remained consistent over time, with no new long-term risks identified. Researchers say these findings mark a turning point in first-line treatment for EGFR-mutated lung cancer by potentially delaying resistance and extending patient survival.
Read Announcement- Drug:
- RYBREVANT (amivantamab-vmjw)
- Announced Date:
- March 26, 2025
- Indication:
- Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
Announcement
Johnson & Johnson announced results for the gold standard endpoint in cancer treatment of overall survival (OS) from the Phase 3 MARIPOSA study. Head-to-head comparison data versus osimertinib showed RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) significantly extended OS in the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations.
AI Summary
Johnson & Johnson announced positive overall survival (OS) results from the Phase 3 MARIPOSA study. This study compared the combination of RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) versus osimertinib in patients with locally advanced or metastatic non‐small cell lung cancer (NSCLC) carrying EGFR exon 19 deletions or L858R substitutions. The head‐to‐head data showed that the combination significantly extended OS, with the median not yet reached and a projected improvement of over one year beyond the three-year median observed with osimertinib.
The trial positions RYBREVANT plus LAZCLUZE as a promising first-line treatment option for patients with EGFR-mutated NSCLC. These findings mark the first study to demonstrate a statistically significant and clinically meaningful OS benefit over the current standard therapy, offering hope for improved survival and quality of life for lung cancer patients.
Read Announcement- Drug:
- RYBREVANT (amivantamab-vmjw)
- Announced Date:
- September 19, 2024
- Indication:
- Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
Announcement
Johnson & Johnson's announced that on Thursday, the FDA approved Rybrevant (amivantamab-vmjw) in combination with standard-of-care chemotherapy (carboplatin and pemetrexed) for locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.
Read Announcement- Drug:
- RYBREVANT (amivantamab-vmjw)
- Announced Date:
- September 14, 2024
- Indication:
- Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
Announcement
Johnson & Johnson announced updated results from the Phase 3 MARIPOSA-2 study which showed RYBREVANT® (amivantamab-vmjw) combined with chemotherapy led to consistent benefit across post-progression outcomes in adult patients with previously treated non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations.
AI Summary
Johnson & Johnson announced updated results from the Phase 3 MARIPOSA-2 study showing that RYBREVANT® (amivantamab-vmjw) combined with chemotherapy provided consistent benefits in post-progression outcomes for adult patients with previously treated non-small cell lung cancer (NSCLC) who have EGFR exon 19 deletions or L858R substitution mutations.
The study reported that at an 18-month follow-up, 50% of patients receiving the combination were still alive compared to 40% treated with chemotherapy alone, indicating a positive trend toward improved overall survival. Additionally, the data showed a significant extension in median time to treatment discontinuation and a reduction in the risk of symptomatic progression, along with a longer time to the next therapy. These improvements suggest that the RYBREVANT® plus chemotherapy regimen may offer a new, promising option for patients with limited treatment alternatives after previous therapies.
Read Announcement- Drug:
- RYBREVANT (amivantamab-vmjw)
- Announced Date:
- September 10, 2024
- Indication:
- Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
Announcement
, Johnson & Johnson announced results from the open-label Phase 2 SKIPPirr study, which evaluated additional prophylactic strategies to reduce the incidence of infusion-related reactions (IRRs) with intravenous (IV) Rybrevant (amivantamab-vmjw) in patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations.
AI Summary
Johnson & Johnson announced promising results from its open-label Phase 2 SKIPPirr study. This study evaluated an enhanced pre-medication regimen using 8‑mg dexamethasone to reduce infusion-related reactions (IRRs) in patients with advanced non-small cell lung cancer (NSCLC) who have EGFR exon 19 deletions or L858R substitution mutations. In the study, patients received dexamethasone twice daily for two days before their first infusion of intravenous Rybrevant, which led to a 22.5% rate of IRRs.
This represents a significant three-fold reduction compared to the 67.4% incidence historically observed with standard IRR management. The findings indicate that this easily accessible prophylactic strategy can improve the treatment experience by lowering the occurrence of IRRs, ensuring patients can continue therapy with fewer interruptions.
Read Announcement- Drug:
- RYBREVANT (amivantamab-vmjw)
- Announced Date:
- September 8, 2024
- Indication:
- Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
Announcement
Johnson & Johnson announced longer follow-up data from the landmark Phase 3 MARIPOSA study which showed first-line treatment with RYBREVANT® (amivantamab-vmjw) combined with LAZCLUZE™ (lazertinib) provided consistent benefit across long-term outcomes compared to osimertinib monotherapy in adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations.
AI Summary
Johnson & Johnson recently shared longer follow-up results from the Phase 3 MARIPOSA study, which evaluated a chemotherapy-free treatment for advanced non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or L858R mutations. The study showed that first-line treatment with the combination of RYBREVANT® (amivantamab-vmjw) and LAZCLUZE™ (lazertinib) provided consistent long-term benefits compared to osimertinib monotherapy. At nearly three years of follow-up, patients on the RYBREVANT® plus LAZCLUZE™ regimen demonstrated an improved overall survival trend. By targeting both the EGFR and MET pathways, this combination therapy offers the potential for prolonged disease control and improved survival outcomes in patients with this specific type of NSCLC. Future ongoing assessments will continue to monitor these long-term outcomes and further support the benefit of the combination therapy.
Read Announcement- Drug:
- RYBREVANT (amivantamab-vmjw)
- Announced Date:
- August 20, 2024
- Indication:
- Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
Announcement
Johnson & Johnson announced that that the U.S. Food and Drug Administration (FDA) approved RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.1,2
AI Summary
Johnson & Johnson announced that the U.S. FDA approved the combination of RYBREVANT® (amivantamab-vmjw) and LAZCLUZE™ (lazertinib) for first-line treatment of adults with locally advanced or metastatic non–small cell lung cancer (NSCLC) carrying EGFR exon 19 deletions or exon 21 L858R substitution mutations, as determined by an FDA-approved test. This approval is based on positive results from the Phase 3 MARIPOSA study, which found that the combination reduced the risk of disease progression or death by 30 percent compared to osimertinib, with a nine-month longer median duration of response. The regimen is notable as the first and only chemotherapy-free, multitargeted treatment approved for patients with these EGFR mutations, offering a promising alternative to traditional chemotherapy and aiming to improve patient outcomes and quality of life.
Read Announcement
Posdinemab FDA Regulatory Events
Posdinemab is a drug developed by Johnson & Johnson for the following indication: For Alzheimer's disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- posdinemab
- Announced Date:
- July 24, 2025
- Indication:
- For Alzheimer's disease
Announcement
Johnson & Johnson announced promising new data from its Alzheimer's disease (AD) research program will be presented at the Alzheimer's Association International Conference (AAIC), taking place July 27–31 in Toronto, Canada.
AI Summary
Johnson & Johnson announced it will present promising new data at the Alzheimer’s Association International Conference (AAIC) in Toronto, July 27–31. Early results from the Phase 2b AuTonomy posdinemab trial show leadership in using multiple biomarkers to detect Alzheimer’s disease early.
The findings emphasize the central role of tau protein in disease progression. Researchers reported that the plasma biomarker pTau217 strongly predicts cognitive decline in at-risk individuals. This could help doctors monitor patients and start treatments sooner.
Johnson & Johnson and Gates Ventures will share insights from the Global Neurodegeneration Proteomics Consortium at AAIC. As the world’s largest proteomics database for neurodegenerative diseases, it offers large, diverse datasets. Their featured session will highlight how these resources can speed up discoveries and identify new treatment targets for Alzheimer’s and related dementias.
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TALVEY FDA Regulatory Events
TALVEY is a drug developed by Johnson & Johnson for the following indication: In patients with relapsed or refractory multiple myeloma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TALVEY
- Announced Date:
- June 15, 2025
- Indication:
- In patients with relapsed or refractory multiple myeloma
Announcement
Johnson & Johnson announced new results from the Phase 2 RedirecTT-1 study evaluating the investigational combination of TALVEY® (talquetamab-tgvs), the first U.S. Food and Drug Administration (FDA)-approved GPRC5D-directed bispecific antibody, and TECVAYLI® (teclistamab-cqyv), the first FDA-approved BCMA-directed bispecific antibody.
AI Summary
Johnson & Johnson announced promising Phase 2 RedirecTT-1 study results for a novel treatment approach in relapsed/refractory multiple myeloma patients with extramedullary disease. The study evaluated an investigational combination of TALVEY® (talquetamab-tgvs) and TECVAYLI® (teclistamab-cqyv). TALVEY® is the first FDA-approved bispecific antibody that targets GPRC5D, while TECVAYLI® is the first approved bispecific antibody targeting BCMA. This combination achieved a high overall response rate of 78.9 percent, with more than half of the patients reaching a complete response or better.
The dual targeting of GPRC5D and BCMA may help overcome therapy resistance by reducing antigen escape, offering a novel off-the-shelf approach for patients with limited treatment options. These results mark an important advancement in providing deeper and more durable responses for individuals battling this aggressive form of multiple myeloma.
Read Announcement- Drug:
- TALVEY
- Announced Date:
- September 27, 2024
- Indication:
- In patients with relapsed or refractory multiple myeloma
Announcement
Johnson & Johnson announced updated results from the investigational Phase 1b TRIMM-2 study evaluating the combination of TALVEY® (talquetamab-tgvs) with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) and pomalidomide in patients with relapsed or refractory multiple myeloma that demonstrated an overall response rate (ORR) of 82 percent, further supporting the investigation of this combination.
AI Summary
Johnson & Johnson announced updated results from its investigational Phase 1b TRIMM-2 study in patients with relapsed or refractory multiple myeloma. The study evaluated a novel combination therapy that includes TALVEY® (talquetamab-tgvs), DARZALEX FASPRO® (a formulation of daratumumab with hyaluronidase-fihj), and pomalidomide. The combination demonstrated an 82% overall response rate, highlighting its promising efficacy in a patient group that has undergone several prior lines of therapy. The high response rate indicates that this combination could offer a new treatment option for patients who have limited alternatives and whose disease is resistant to standard treatments. These encouraging results support continued investigation of this regimen, as Johnson & Johnson seeks to improve outcomes and quality of life for multiple myeloma patients facing advanced, hard-to-treat disease.
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JNJ-4496 FDA Regulatory Events
JNJ-4496 is a drug developed by Johnson & Johnson for the following indication: In patients with relapsed or refractory large B-cell lymphoma (R/R LBCL).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- JNJ-4496
- Announced Date:
- June 13, 2025
- Indication:
- In patients with relapsed or refractory large B-cell lymphoma (R/R LBCL)
Announcement
Johnson & Johnson announced the first clinical data from an ongoing Phase 1b study for JNJ-90014496 (JNJ-4496), an investigational dual-targeting anti-CD19/CD20 bispecific autologous chimeric antigen receptor (CAR) T-cell therapy, being studied in patients with relapsed or refractory large B-cell lymphoma (R/R LBCL) who have not been previously treated with CAR T-cell therapy.
AI Summary
Johnson & Johnson announced promising initial clinical data from a Phase 1b study of JNJ-90014496 (JNJ-4496), a novel dual-targeting CAR T-cell therapy designed to treat relapsed or refractory large B-cell lymphoma in patients who have not previously received CAR T-cell treatment. The therapy targets both CD19 and CD20 proteins found on malignant B-cells, which may help overcome resistance seen with single-target treatments.
At the recommended Phase 2 dose of 75 million CAR+ T-cells, evaluable patients showed encouraging responses. In those who had received one prior therapy, the complete response rate was 80%, while patients with two or more prior therapies achieved a 75% complete response rate. Importantly, the study reported a manageable safety profile with no cases of severe cytokine release syndrome. These findings highlight the potential of JNJ-4496 as a new treatment option for aggressive lymphoma patients.
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AKEEGA FDA Regulatory Events
AKEEGA is a drug developed by Johnson & Johnson for the following indication: In Disease Progression For BRCA-Altered Prostate Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- AKEEGA
- Announced Date:
- June 3, 2025
- Indication:
- In Disease Progression For BRCA-Altered Prostate Cancer
Announcement
Johnson & Johnson announced first results from the Phase 3, randomized, double-blind, placebo-controlled AMPLITUDE study evaluating the combination of niraparib and abiraterone acetate plus prednisone (AAP) in patients with metastatic castration-sensitive prostate cancer (mCSPC) with homologous recombination repair (HRR) genetic alterations including BRCA
AI Summary
Johnson & Johnson announced the first results from the Phase 3 AMPLITUDE study, which looked at a new treatment option for patients with metastatic castration-sensitive prostate cancer (mCSPC) who have homologous recombination repair (HRR) genetic alterations, including BRCA mutations. In this randomized, double-blind, placebo-controlled trial, the combination of niraparib and abiraterone acetate plus prednisone significantly improved outcomes. Specifically, patients with BRCA alterations experienced nearly a 50 percent reduction in the risk of radiographic progression or death compared to those receiving the standard care. The study showed that this treatment not only delayed cancer progression but also postponed the worsening of symptoms. These promising results suggest that combining a PARP inhibitor with an androgen receptor pathway inhibitor may offer a valuable and new personalized treatment strategy for patients facing more aggressive forms of mCSPC.
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RYBREVANT®(amivantamab) FDA Regulatory Events
RYBREVANT®(amivantamab) is a drug developed by Johnson & Johnson for the following indication: For Advanced EGFR-Mutated Non-Small Cell Lung Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- RYBREVANT®(amivantamab)
- Announced Date:
- April 7, 2025
- Indication:
- For Advanced EGFR-Mutated Non-Small Cell Lung Cancer
Announcement
Halozyme Therapeutics, Inc. announced that Janssen-Cilag International NV, a Johnson & Johnson company, has received European Commission (EC) marketing authorization of the subcutaneous (SC) formulation of RYBREVANT® (amivantamab), in combination with LAZCLUZE® (lazertinib), for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations.
AI Summary
Halozyme Therapeutics announced that Janssen-Cilag International NV, a Johnson & Johnson company, has received European Commission (EC) marketing authorization for the subcutaneous formulation of RYBREVANT® (amivantamab). This approval is for use in combination with LAZCLUZE® (lazertinib) as a first-line treatment for adult patients with advanced non-small cell lung cancer (NSCLC) who have specific EGFR mutations, including exon 19 deletions or exon 21 L858R substitution mutations.
The subcutaneous formulation utilizes Halozyme’s innovative ENHANZE® drug delivery technology, designed to reduce administration time and lower the risk of infusion-related reactions, thereby potentially easing the burden on healthcare systems. Additionally, the treatment is approved as a monotherapy for patients with advanced NSCLC with EGFR exon 20 insertion mutations after platinum-based therapy has failed, supported by positive data from the Phase III PALOMA-3 study.
Read Announcement- Drug:
- RYBREVANT®(amivantamab)
- Announced Date:
- February 3, 2025
- Indication:
- For Advanced EGFR-Mutated Non-Small Cell Lung Cancer
Announcement
Halozyme Therapeutics, Inc. nnounced that Janssen-Cilag International NV, a Johnson & Johnson company, received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommending an extension of marketing authorisation for a subcutaneous (SC) formulation of RYBREVANT® (amivantamab) in combination with LAZCLUZE® (lazertinib) for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, and as a monotherapy for the treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after failure of platinum-based therapy.
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LAZCLUZE FDA Regulatory Timeline and Events
LAZCLUZE is a drug developed by Johnson & Johnson for the following indication: For treatment of patients with EGFR-mutated advanced non-small cell lung cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- LAZCLUZE
- Announced Date:
- March 20, 2025
- Indication:
- For treatment of patients with EGFR-mutated advanced non-small cell lung cancer
Announcement
Johnson & Johnson announced today that new data from its industry-leading oncology pipeline will be presented at the 2025 European Lung Cancer Congress (ELCC), including overall survival (OS) results from the Phase 3 MARIPOSA study evaluating RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) versus osimertinib in the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations.
AI Summary
Johnson & Johnson announced that new data from its oncology pipeline will be showcased at the 2025 European Lung Cancer Congress. The highlight is the overall survival results from the Phase 3 MARIPOSA study, which compares the combination of RYBREVANT® (amivantamab-vmjw) and LAZCLUZE™ (lazertinib) against osimertinib. This study focuses on first‐line treatment in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have EGFR exon 19 deletions or L858R substitution mutations. The new overall survival data suggest a significant improvement over osimertinib, offering new hope for longer survival in these patients. Additional presentations at the congress will also cover a dermatologic regimen designed to prevent skin reactions and explore switching to subcutaneous administration, further highlighting innovative strategies in NSCLC treatment.
Read Announcement- Drug:
- LAZCLUZE
- Announced Date:
- March 10, 2025
- Indication:
- For treatment of patients with EGFR-mutated advanced non-small cell lung cancer
Announcement
Johnson & Johnson announced today that Health Canada has issued a Notice of Compliance (NOC) for LAZCLUZE® (lazertinib) in combination with RYBREVANT® (amivantamab) for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations.1
AI Summary
Johnson & Johnson announced that Health Canada has granted a Notice of Compliance (NOC) for LAZCLUZE® (lazertinib) used in combination with RYBREVANT® (amivantamab) as a first‐line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 19 deletions or exon 21 L858R substitution mutations. This approval marks the first chemotherapy-free regimen in Canada offering targeted treatment for these specific NSCLC patients. Results from the Phase 3 MARIPOSA study demonstrated that the combination reduced the risk of disease progression or death by 30% compared to osimertinib, providing a significant improvement in progression-free survival. Janssen Inc., a Johnson & Johnson company, is the marketing authorization holder for this breakthrough therapy, which underscores the continued commitment to advancing precision medicine and offering improved first-line treatment options for lung cancer patients.
Read Announcement- Drug:
- LAZCLUZE
- Announced Date:
- March 6, 2025
- Indication:
- For treatment of patients with EGFR-mutated advanced non-small cell lung cancer
Announcement
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 6 March 2025, approved lazertinib (brand name Lazcluze) for adults with non-small cell lung cancer that has spread to other parts of the body and has undergone specific changes in a gene called epidermal growth factor receptor (EGFR).
Read Announcement- Drug:
- LAZCLUZE
- Announced Date:
- January 21, 2025
- Indication:
- For treatment of patients with EGFR-mutated advanced non-small cell lung cancer
Announcement
Janssen-Cilag International NV, a Johnson & Johnson company, announced that the European Commission (EC) has approved a Marketing Authorisation (MA) for LAZCLUZE®▼(lazertinib), in combination with RYBREVANT®▼(amivantamab), for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or exon 21 L858R (L858R) substitution mutations.
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JNJ-2113 FDA Regulatory Timeline and Events
JNJ-2113 is a drug developed by Johnson & Johnson for the following indication: Severely Active Ulcerative Colitis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- JNJ-2113
- Announced Date:
- March 10, 2025
- Indication:
- Severely Active Ulcerative Colitis
Announcement
Protagonist Therapeutics, Inc. announced positive topline results from ANTHEM-UC, a Phase 2b study of icotrokinra (JNJ-2113), the first investigational targeted oral peptide that selectively blocks the IL-23 receptor, in adults with moderately to severely active ulcerative colitis (UC).
AI Summary
Protagonist Therapeutics, Inc. announced positive topline results from the ANTHEM-UC Phase 2b study evaluating icotrokinra (JNJ-2113), the first investigational targeted oral peptide to selectively block the IL-23 receptor. The study involved adults with moderately to severely active ulcerative colitis. All three doses tested met the primary endpoint, with the highest dose achieving a clinical response rate of 63.5% at Week 12, compared to 27.0% in the placebo group. Additionally, at this dose, 30.2% of patients reached clinical remission versus 11.1% for placebo. The safety profile was favorable, and clinical remission and response rates continued to improve through Week 28. These promising results indicate that icotrokinra has the potential to transform the treatment landscape for ulcerative colitis, offering a new and convenient once-daily oral treatment option for patients suffering from this chronic inflammatory condition.
Read Announcement- Drug:
- JNJ-2113
- Announced Date:
- March 8, 2025
- Indication:
- Severely Active Ulcerative Colitis
Announcement
Protagonist Therapeutics announced new icotrokinra (JNJ-2113) data from the comprehensive Phase 3 clinical program and the planned initiation of the first-ever head-to-head study in plaque psoriasis (PsO) seeking to demonstrate the superiority of an oral pill, icotrokinra, compared to an injectable biologic, ustekinumab.
AI Summary
Protagonist Therapeutics recently announced encouraging new data for icotrokinra (JNJ-2113) from its comprehensive Phase 3 clinical program in moderate‐to‐severe plaque psoriasis (PsO). In the ICONIC-LEAD study, nearly half of patients achieved completely clear skin at Week 24, demonstrating significant skin clearance and a favorable safety profile in both adults and adolescents. Based on these promising results and additional positive outcomes from comparisons with another oral therapy, the company, in collaboration with Johnson & Johnson, is moving forward with a groundbreaking Phase 3 study—ICONIC-ASCEND. This upcoming head-to-head trial will be the first to compare an oral pill, icotrokinra, directly against an injectable biologic, ustekinumab, in patients with plaque psoriasis, aiming to prove the superiority of the pill. If successful, the study could offer a more convenient treatment option and potentially shift the current psoriasis therapy landscape.
Read Announcement- Drug:
- JNJ-2113
- Announced Date:
- November 18, 2024
- Indication:
- Severely Active Ulcerative Colitis
Announcement
Johnson & Johnson announced positive topline results from ICONIC-LEADa, a pivotal Phase 3 investigational study of icotrokinra (JNJ-2113), the first targeted oral peptide that selectively blocks the IL-23 receptor, in adults and adolescents 12 years of age and older with moderate to severe plaque psoriasis (PsO).
AI Summary
Johnson & Johnson announced positive topline results from ICONIC‑LEADa, a pivotal Phase 3 study evaluating icotrokinra (JNJ‑2113) in adults and adolescents aged 12 and older with moderate to severe plaque psoriasis. Icotrokinra is the first targeted oral peptide that selectively blocks the IL‑23 receptor, a key driver of inflammation in psoriasis.
The study met its co‑primary endpoints at week 16, with nearly two‑thirds (64.7%) of patients achieving clear or almost clear skin, as measured by the Investigator’s Global Assessment (IGA) scores of 0/1. Improvement continued through week 24, where 74.1% of patients reached the IGA 0/1 response, along with significant improvements in the Psoriasis Area and Severity Index (PASI 90). The safety profile was similar to previous Phase 2 studies. Comprehensive results will be presented at upcoming medical congresses, offering hope for a once‑daily oral treatment option for plaque psoriasis.
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SPRAVATO FDA Regulatory Events
SPRAVATO is a drug developed by Johnson & Johnson for the following indication: For adults with treatment-resistant depression.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SPRAVATO
- Announced Date:
- January 21, 2025
- Indication:
- For adults with treatment-resistant depression
Announcement
Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) approval of a supplemental New Drug Application (sNDA) for SPRAVATO® (esketamine) CIII nasal spray, making this innovative treatment the first and only monotherapy for adults living with major depressive disorder (MDD) who have had an inadequate response to at least two oral antidepressants.
AI Summary
Johnson & Johnson announced that the U.S. FDA has approved a supplemental New Drug Application (sNDA) for SPRAVATO® (esketamine) CIII nasal spray. This makes SPRAVATO® the first and only monotherapy available for adults with major depressive disorder (MDD) who have not had a sufficient response to at least two oral antidepressants.
Clinical trials showed that SPRAVATO® used on its own provided fast and meaningful relief from depressive symptoms. Many patients experienced improvements as early as 24 hours after treatment, with these benefits sustained through four weeks. This approval offers a new treatment option for those suffering from treatment-resistant depression, addressing a critical need in mental health care by giving patients an alternative to daily oral antidepressants.
Read Announcement- Drug:
- SPRAVATO
- Announced Date:
- July 22, 2024
- Indication:
- For adults with treatment-resistant depression
Announcement
Johnson & Johnson announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval of SPRAVATO® (esketamine) CIII nasal spray as a monotherapy for adults living with treatment-resistant depression (TRD).
AI Summary
Johnson & Johnson has submitted a supplemental New Drug Application (sNDA) to the U.S. FDA, seeking approval of SPRAVATO® (esketamine) CIII nasal spray as a monotherapy for adults with treatment-resistant depression (TRD). This submission is backed by positive results from a Phase 4 study that showed a rapid improvement in depressive symptoms—noticeable as early as 24 hours after the first dose— with benefits continuing for at least four weeks. The data supports over a decade of research, including 31 clinical trials and extensive real-world use, which together underline the safety and effectiveness of SPRAVATO®. If approved, this new monotherapy option could help patients who have not responded well to traditional antidepressants, providing a much-needed treatment alternative for those suffering from TRD.
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RYBREVANT® (amivantamab-vmjw) FDA Regulatory Events
RYBREVANT® (amivantamab-vmjw) is a drug developed by Johnson & Johnson for the following indication: For patients with EGFR-mutated advanced lung cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- RYBREVANT® (amivantamab-vmjw)
- Announced Date:
- January 7, 2025
- Indication:
- For patients with EGFR-mutated advanced lung cancer
Announcement
Johnson & Johnson announced positive topline results for the gold standard endpoint in cancer treatment of overall survival (OS) from the Phase 3 MARIPOSA study, evaluating RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) as a first-line therapy for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations.
AI Summary
Johnson & Johnson announced significant topline findings from the Phase 3 MARIPOSA study. The study evaluated the combination of RYBREVANT® (amivantamab-vmjw) and LAZCLUZE™ (lazertinib) as a first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have EGFR exon 19 deletions or L858R substitutions. The chemotherapy-free regimen showed a statistically significant and clinically meaningful improvement in overall survival compared to the standard of care, osimertinib, with median overall survival expected to extend by more than one year.
This result is a key milestone in cancer treatment as overall survival is the gold standard endpoint, directly reflecting the therapy’s impact on extending patients’ lives. The promising data from the MARIPOSA trial offer renewed hope for improved outcomes for patients with EGFR-mutated NSCLC and support this frontline combination approach as a valuable treatment option.
Read Announcement- Drug:
- RYBREVANT® (amivantamab-vmjw)
- Announced Date:
- August 27, 2024
- Indication:
- For patients with EGFR-mutated advanced lung cancer
Announcement
Johnson & Johnson announced that that 11 oral presentations from the Company's industry-leading solid tumor portfolio and pipeline will be featured at the 2024 World Conference on Lung Cancer (WCLC) and the European Society for Medical Oncology (ESMO) 2024 Congress.
AI Summary
Johnson & Johnson announced that 11 oral presentations showcasing its industry-leading solid tumor portfolio and pipeline will be featured at two major conferences next year: the 2024 World Conference on Lung Cancer (WCLC) in San Diego and the 2024 European Society for Medical Oncology (ESMO) Congress in Barcelona. These presentations will highlight key data from studies on lung, colorectal, bladder, and prostate cancers and reflect the Company’s focus on developing targeted treatments for cancers with high unmet needs. The research will provide insights into new approaches, including RYBREVANT® regimens in EGFR-mutated non-small cell lung cancer (NSCLC), among other innovative therapies. According to Dr. Yusri Elsayed, this initiative is part of Johnson & Johnson’s enduring commitment to oncology innovation, emphasizing breakthroughs that aim to transform the treatment landscape for patients with solid tumors.
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