Johnson & Johnson (JNJ) FDA Approvals

Johnson & Johnson's Drugs in the FDA Approval Process

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 AKEEGA, apalutamide, CAPLYTA, DARZALEX, Guselkumab, Icotrokinra, and IMAAVY. 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.

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.

Results - June 3,2025

Phase 3

• 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.

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.

Results - October 2,2024

• 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.

Results - May 3,2024

Phase 2

• Drug: apalutamide
• Announced Date: May 3, 2024
• Indication: For the treatment of prostate cancer (nmCRPC)

Announcement

Johnson & Johnson announced results from the open-label, single-arm Phase 2 Apa-RP study evaluating adjuvant treatment with ERLEADA® (apalutamide) and androgen deprivation therapy (ADT) in patients with HRLPC who have undergone radical prostatectomy (RP).

CAPLYTA (Lumateperone) FDA Regulatory 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.

sNDA Filing - July 8,2025

supplemental New Drug Application (sNDA)

• Drug: CAPLYTA (Lumateperone)
• Announced Date: July 8, 2025
• Indication: Depressive Episodes associated with Bipolar
• Other Companies Involved: NASDAQ:ITCI

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.

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.

Data - June 3,2025

• Drug: DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) + Pomalidomide + Dexamethasone
• Announced Date: June 3, 2025
• Indication: Multiple Myeloma After First / Subsequent Relapse
• Other Companies Involved: NASDAQ:HALO

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.

Application Approved - May 20,2025

• Drug: DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) + Pomalidomide + Dexamethasone
• Announced Date: May 20, 2025
• Indication: Multiple Myeloma After First / Subsequent Relapse
• Other Companies Involved: NASDAQ:HALO

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.

Data - December 8,2024

Phase 3

• Drug: DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) + Pomalidomide + Dexamethasone
• Announced Date: December 8, 2024
• Indication: Multiple Myeloma After First / Subsequent Relapse
• Other Companies Involved: NASDAQ:HALO

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.

sBLA Filing - September 30,2024

sBLA

• Drug: DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) + Pomalidomide + Dexamethasone
• Announced Date: September 30, 2024
• Indication: Multiple Myeloma After First / Subsequent Relapse
• Other Companies Involved: NASDAQ:HALO

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.

Results - September 27,2024

Phase 3

• Drug: DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) + Pomalidomide + Dexamethasone
• Announced Date: September 27, 2024
• Indication: Multiple Myeloma After First / Subsequent Relapse
• Other Companies Involved: NASDAQ:HALO

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.

FDA Approval - July 30,2024

• Drug: DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) + Pomalidomide + Dexamethasone
• Announced Date: July 30, 2024
• Indication: Multiple Myeloma After First / Subsequent Relapse
• Other Companies Involved: NASDAQ:HALO

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.

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.

sBLA Filing - July 29,2025

sBLA

• 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.

Findings Update - June 11,2025

Phase 3b

• 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.

New Data - May 5,2025

Phase 3

• 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.

Enrollment Plan - April 4,2025

Phase 3b

• 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.

FDA Approval - March 20,2025

• 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.

Data - February 21,2025

Phase 3

• 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.

BLA Filing - December 2,2024

sBLA

• 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.

BLA Filing - November 22,2024

BLA

• 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.

FDA Approval - September 11,2024

• 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.

Top-line results - June 20,2024

Phase 3

• Drug: Guselkumab
• Announced Date: June 20, 2024
• Indication: For Treatment Of Adults With Moderately To Severely Active Ulcerative Colitis

Announcement

Johnson & Johnson announced positive topline results from the pivotal Phase 3 GRAVITI investigational study of TREMFYA® (guselkumab) subcutaneous (SC) induction therapy in adult patients with moderately to severely active Crohn's disease.1

AI Summary

Johnson & Johnson announced positive topline results from the pivotal Phase 3 GRAVITI study evaluating TREMFYA® (guselkumab) as a subcutaneous (SC) induction therapy for adult patients with moderately to severely active Crohn’s disease. The study successfully met both co-primary endpoints, with statistically significant and clinically meaningful outcomes for clinical remission and endoscopic response at Week 12. Moreover, all additional secondary endpoints at Weeks 12, 24, and 48 demonstrated significant benefits compared to placebo.

These promising findings build on earlier evidence from the GALAXI trials and position TREMFYA® to be the only IL-23 inhibitor offering both SC and IV induction options. Johnson & Johnson emphasized that having both administration methods provides greater treatment flexibility, which could offer additional therapeutic choices for patients and healthcare providers managing Crohn’s disease.

Icotrokinra FDA Regulatory 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.

NDA Filing - July 21,2025

NDA

• 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.

IMAAVY FDA Regulatory 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.

New Data - June 23,2025

• 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.

FDA approved - April 30,2025

• 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.

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.

Top-line results - March 10,2025

Phase 2b

• Drug: JNJ-2113
• Announced Date: March 10, 2025
• Indication: Severely Active Ulcerative Colitis
• Other Companies Involved: NASDAQ:PTGX

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.

New Data - March 8,2025

Phase 3

• Drug: JNJ-2113
• Announced Date: March 8, 2025
• Indication: Severely Active Ulcerative Colitis
• Other Companies Involved: NASDAQ:PTGX

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.

Positive Results - November 18,2024

Phase 3

• 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.

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.

Clinical Data - June 13,2025

Phase 1b

• 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.

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.

New Data - March 20,2025

Phase 3

• 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.

Notice of Compliance - March 10,2025

Health Canada

• 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.

Approved - March 6,2025

• 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).

Marketing authorization - January 21,2025

MAA

• 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.

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.

Abstract - March 26,2025

• 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.

Designation Grant - March 18,2025

Fast Track

• 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.

Data Publication - February 13,2025

• 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.

Published Results - January 23,2025

Phase 3

• 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.

Provided Update - January 9,2025

BLA Priority Review

• 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.

BLA Filing - August 29,2024

BLA

• 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.

Late-Breaking Data - June 15,2024

Phase 2

• Drug: Nipocalimab
• Announced Date: June 15, 2024
• Indication: Treatment of alloimmunisedc pregnant individuals at high risk of severe HDFN

Announcement

Johnson & Johnson announces patients treated with nipocalimab demonstrated statistically significant (P=0.002) and clinically meaningful improvement in ClinESSDAIa score versus placebo at 24 weeks compared to baseline (primary endpoint) in the Phase 2 DAHLIAS dose-ranging study of nipocalimab in adult patients living with Sjögren's disease (SjD).

AI Summary

Johnson & Johnson announced positive results from its Phase 2 DAHLIAS study of nipocalimab in adult patients with Sjögren’s disease. In the study, patients receiving nipocalimab at a dose of 15 mg/kg showed a statistically significant (P=0.002) and clinically meaningful improvement in the ClinESSDAIa score at 24 weeks compared to baseline and to the placebo group. This primary endpoint was met as early as Week 4 and continued to improve throughout the treatment period. The results mark the first positive data for nipocalimab in Sjögren’s disease, a chronic autoimmune condition that affects millions worldwide. The findings suggest that nipocalimab may offer a new, effective approach for treating a disease that currently has few advanced treatment options.

PONVORY (ponesimod) FDA Regulatory Events

PONVORY (ponesimod) is a drug developed by Johnson & Johnson for the following indication: relapsing forms of multiple sclerosis (MS). 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.

Provided Update - May 30,2024

NDA

• Drug: PONVORY (ponesimod)
• Announced Date: May 30, 2024
• Indication: relapsing forms of multiple sclerosis (MS)

Announcement

Vanda Pharmaceuticals Inc. announced that ownership of the U.S. New Drug Application and Investigational New Drug Applications for PONVORY® (ponesimod) has been transferred to Vanda from a Johnson & Johnson Company, which now fully allows Vanda to commercialize PONVORY® in the U.S.

AI Summary

Vanda Pharmaceuticals Inc. announced a significant milestone as it has taken full ownership of the U.S. New Drug Application and Investigational New Drug Applications for PONVORY® (ponesimod) from a Johnson & Johnson Company. With this transfer, Vanda now holds the complete rights to commercialize PONVORY® in the United States, allowing the company to move forward with a full commercialization strategy and expand its clinical development programs.

PONVORY® is an approved oral treatment for multiple sclerosis, and this change in ownership gives Vanda the freedom to develop new initiatives. The company plans to boost its presence in the U.S. market by establishing a dedicated specialty sales force, launching a prescriber awareness program, and implementing a comprehensive marketing campaign, all aimed at enhancing patient access and providing improved treatment options for those affected by inflammatory disorders.

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.

Promising data - July 24,2025

• 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.

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.

Results - March 26,2025

Phase 3

• Drug: RYBREVANT (amivantamab-vmjw)
• Announced Date: March 26, 2025
• Indication: Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
• Other Companies Involved: NASDAQ:GH

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.

FDA Approval - September 19,2024

FDA Approved

• Drug: RYBREVANT (amivantamab-vmjw)
• Announced Date: September 19, 2024
• Indication: Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
• Other Companies Involved: NASDAQ:GH

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.

Results - September 14,2024

Phase 3

• Drug: RYBREVANT (amivantamab-vmjw)
• Announced Date: September 14, 2024
• Indication: Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
• Other Companies Involved: NASDAQ:GH

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.

Results - September 10,2024

• Drug: RYBREVANT (amivantamab-vmjw)
• Announced Date: September 10, 2024
• Indication: Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
• Other Companies Involved: NASDAQ:GH

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.

Data - September 8,2024

Phase 3

• Drug: RYBREVANT (amivantamab-vmjw)
• Announced Date: September 8, 2024
• Indication: Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
• Other Companies Involved: NASDAQ:GH

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.

FDA Approval - August 20,2024

FDA Approved

• Drug: RYBREVANT (amivantamab-vmjw)
• Announced Date: August 20, 2024
• Indication: Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
• Other Companies Involved: NASDAQ:GH

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.

Regulatory Update - July 3,2024

• Drug: RYBREVANT (amivantamab-vmjw)
• Announced Date: July 3, 2024
• Indication: Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
• Other Companies Involved: NASDAQ:GH

Announcement

Johnson & Johnson announced that that Health Canada, through a Priority Review, has issued a Notice of Compliance (NOC) for RYBREVANT® (amivantamab) in combination with platinum-based chemotherapy (carboplatin and pemetrexed) for the first-line treatment of adult patients with locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) Exon 20 insertion mutations.1

AI Summary

Johnson & Johnson announced that Health Canada has granted a Notice of Compliance for RYBREVANT® (amivantamab) when used in combination with platinum-based chemotherapy (carboplatin and pemetrexed) as a first-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that features EGFR Exon 20 insertion mutations. This regulatory milestone, achieved through a Priority Review, marks a significant advancement in addressing an aggressive form of lung cancer that currently has limited treatment options and a poorer prognosis. The recent approval is supported by data from the Phase 3 PAPILLON study, which showed that the combination therapy reduced the risk of disease progression or death by 60% compared to chemotherapy alone. Health Canada’s decision underscores the potential of targeted therapies like RYBREVANT® to provide improved outcomes and renewed hope for patients with this rare mutation.

IND Filing - June 17,2024

BLA

• Drug: RYBREVANT (amivantamab-vmjw)
• Announced Date: June 17, 2024
• Indication: Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
• Other Companies Involved: NASDAQ:GH

Announcement

Johnson & Johnson announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for a fixed combination of amivantamab and recombinant human hyaluronidase for subcutaneous administration (SC amivantamab) for all currently approved or submitted indications of intravenous (IV) RYBREVANT® (amivantamab-vmjw) in certain patients with non-small cell lung cancer (NSCLC).

AI Summary

Johnson & Johnson has submitted a Biologics License Application (BLA) to the U.S. FDA for a new fixed combination treatment, which pairs amivantamab with recombinant human hyaluronidase for subcutaneous administration (SC amivantamab). This submission covers all currently approved or pending indications of intravenous RYBREVANT® (amivantamab-vmjw) in select non-small cell lung cancer (NSCLC) patients with EGFR mutations. Data from the Phase 3 PALOMA-3 study showed that SC amivantamab provided a comparable overall response to its IV counterpart while significantly reducing infusion-related reactions by five-fold and shortening the administration time to about five minutes. Additionally, the study observed improvements in overall survival, progression-free survival, and duration of response. This advancement offers a more convenient option for patients and may enhance treatment experiences with NSCLC therapy.

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.

Top-line results - January 7,2025

Phase 3

• 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.

Provided Update - August 27,2024

• 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.

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.

Marketing authorization - April 7,2025

European Commission Marketing Authorization

• 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.

Positive Opinion - February 3,2025

EMA

• 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.

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.

Approved - January 21,2025

supplemental New Drug Application (sNDA)

• 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.

NDA Filing - July 22,2024

supplemental New Drug Application (sNDA)

• 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.

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.

sBLA Filing - June 17,2025

sBLA

• 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).

TALVEY FDA Regulatory Timeline and 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.

Results - June 15,2025

Phase 2

• 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.

updated results - September 27,2024

Phase 2

• 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.

Data - June 14,2024

Phase 1/2

• Drug: TALVEY
• Announced Date: June 14, 2024
• Indication: In patients with relapsed or refractory multiple myeloma

Announcement

Johnson & Johnson announced that long-term data from the Phase 1/2 MonumenTAL-1 study showed that with 20 to 30 months of median follow-up, triple-class-exposed patients with relapsed or refractory multiple myeloma (RRMM) who were treated with TALVEY® (talquetamab-tgvs) maintained high overall response rates (ORR) and durable responses, irrespective of whether they had received prior T-cell redirection therapy.1

AI Summary

Johnson & Johnson recently reported encouraging long-term results from the Phase 1/2 MonumenTAL-1 study in patients with relapsed or refractory multiple myeloma. After a median follow-up of 20 to 30 months, patients who had already been exposed to three major classes of myeloma treatments maintained high overall response rates when treated with TALVEY® (talquetamab-tgvs). Notably, the study found that the durability of these responses did not depend on whether patients had received prior T-cell redirection therapy. The data, which included patients receiving a 0.8 mg/kg biweekly dosing schedule, underscore TALVEY’s potential as an effective and versatile treatment option. These findings offer hope by showing that TALVEY® can provide sustained benefits in a challenging patient population with limited treatment choices.

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.

FDA Priority Review - July 17,2025

NDA

• 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.

New Data - April 26,2025

Phase 2b

• 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.

New Data - April 21,2025

• 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.

IND Filing - January 15,2025

IND

• 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.

Results - September 15,2024

Phase 2b

• 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.

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.

Study Results - May 5,2024

Phase 1

• Drug: TAR-210
• Announced Date: May 5, 2024
• Indication: In Patients With High-Risk And Intermediate-Risk Non-Muscle-Invasive Bladder Cancer,

Announcement

Johnson & Johnson announced updated results from an open-label, multicenter, multicohort Phase 1 study of the safety and efficacy of TAR-210, an intravesical targeted releasing system designed to provide sustained, local release of erdafitinib into the bladder, in patients with non–muscle-invasive bladder cancer (NMIBC) with select FGFR alterations. T

TECVAYLI FDA Regulatory 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.

New Data - December 8,2024

• 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.

VELYS™ Robotic-Assisted Solution FDA Regulatory Events

VELYS™ Robotic-Assisted Solution is a drug developed by Johnson & Johnson for the following indication: in Unicompartmental Knee Arthroplasty (UKA). 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.

Provided Update - June 7,2024

• Drug: VELYS™ Robotic-Assisted Solution
• Announced Date: June 7, 2024
• Indication: in Unicompartmental Knee Arthroplasty (UKA).

Announcement

Johnson & Johnson MedTech* announced that DePuy Synthes, The Orthopaedics Company of Johnson & Johnson**, has received 510(k) FDA clearance for the clinical application of the VELYS™ Robotic-Assisted Solution in Unicompartmental Knee Arthroplasty (UKA).

Johnson & Johnson FDA Events - Frequently Asked Questions

Has Johnson & Johnson received FDA approval?

Yes, Johnson & Johnson (JNJ) has received FDA approval for RYBREVANT (amivantamab-vmjw). This page tracks recent and historical FDA regulatory events related to Johnson & Johnson's drug portfolio.

What drugs has Johnson & Johnson submitted to the FDA?

In the past two years, Johnson & Johnson (JNJ) has reported FDA regulatory activity for the following drugs: Guselkumab, RYBREVANT (amivantamab-vmjw), Nipocalimab, DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) + Pomalidomide + Dexamethasone, TAR-200, LAZCLUZE, TALVEY, JNJ-2113, IMAAVY, RYBREVANT®(amivantamab), SPRAVATO, RYBREVANT® (amivantamab-vmjw), apalutamide, posdinemab, Icotrokinra, CAPLYTA (Lumateperone), STELARA, JNJ-4496, AKEEGA, TECVAYLI, VELYS™ Robotic-Assisted Solution, PONVORY (ponesimod) and TAR-210.

What is the most recent FDA event for Johnson & Johnson?

The most recent FDA-related event for Johnson & Johnson occurred on July 29, 2025, involving Guselkumab. The update was categorized as "sBLA Filing," with the company reporting: "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)."

What conditions do Johnson & Johnson's current drugs treat?

Current therapies from Johnson & Johnson in review with the FDA target conditions such as:

• For Treatment Of Adults With Moderately To Severely Active Ulcerative Colitis - Guselkumab
• Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations - RYBREVANT (amivantamab-vmjw)
• Treatment of alloimmunisedc pregnant individuals at high risk of severe HDFN - Nipocalimab
• Multiple Myeloma After First / Subsequent Relapse - DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) + Pomalidomide + Dexamethasone
• In patients with intermediate risk non–muscle-invasive bladder cancer - TAR-200
• For treatment of patients with EGFR-mutated advanced non-small cell lung cancer - LAZCLUZE
• In patients with relapsed or refractory multiple myeloma - TALVEY
• Severely Active Ulcerative Colitis - JNJ-2113
• For the treatment of generalized myasthenia gravis (gMG). - IMAAVY
• For Advanced EGFR-Mutated Non-Small Cell Lung Cancer - RYBREVANT®(amivantamab)
• For adults with treatment-resistant depression - SPRAVATO
• For patients with EGFR-mutated advanced lung cancer - RYBREVANT® (amivantamab-vmjw)
• For the treatment of prostate cancer (nmCRPC) - apalutamide
• For Alzheimer's disease - posdinemab
• For adults and adolescents with plaque psoriasis - Icotrokinra
• Depressive Episodes associated with Bipolar - CAPLYTA (Lumateperone)
• For the treatment of pediatric Crohn’s disease - STELARA
• In patients with relapsed or refractory large B-cell lymphoma (R/R LBCL) - JNJ-4496
• In Disease Progression For BRCA-Altered Prostate Cancer - AKEEGA
• For patients with newly diagnosed multiple myeloma - TECVAYLI
• in Unicompartmental Knee Arthroplasty (UKA). - VELYS™ Robotic-Assisted Solution
• relapsing forms of multiple sclerosis (MS) - PONVORY (ponesimod)
• In Patients With High-Risk And Intermediate-Risk Non-Muscle-Invasive Bladder Cancer, - TAR-210