This section highlights FDA-related milestones and regulatory updates for drugs developed by Teva Pharmaceutical Industries (TEVA).
Over the past two years, Teva Pharmaceutical Industries has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
AJOVY®, duvakitug, risperidone, TEV-53408, TEV-749, and TVB-009P. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
AJOVY® (fremanezumab) - FDA Regulatory Timeline and Events
AJOVY® (fremanezumab) is a drug developed by Teva Pharmaceutical Industries for the following indication: For Episodic Migraine in Children.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- AJOVY® (fremanezumab)
- Announced Date:
- April 7, 2025
- Indication:
- For Episodic Migraine in Children
Announcement
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for AJOVY® (fremanezumab-vfrm) to expand the indication to include the prevention of episodic migraine in children and adolescent patients aged 6-17 years who weigh 45 kilograms (99 pounds) or more.
AI Summary
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for AJOVY® (fremanezumab-vfrm). The application seeks to expand the drug’s use to include the prevention of episodic migraine in children and adolescents aged 6-17 years who weigh at least 45 kilograms (99 pounds).
If approved, AJOVY will become the first calcitonin gene-related peptide (CGRP) antagonist available for migraine prevention in both adults and pediatric patients. The move addresses a significant unmet need for effective migraine treatments in younger populations. Positive results from the Phase 3 SPACE trial, demonstrating substantial reductions in monthly migraine and headache days along with a consistent safety profile, support the application. This development reflects Teva’s ongoing commitment to expanding access to innovative treatments for diverse patient groups.
Read Announcement- Drug:
- AJOVY® (fremanezumab)
- Announced Date:
- December 4, 2024
- Indication:
- For Episodic Migraine in Children
Announcement
Teva Pharmaceutical presented positive data from its Phase 3 SPACE study evaluating the efficacy and safety of AJOVY® (fremanezumab) for the prevention of episodic migraine in children and adolescent patients aged 6-17 years.1
AI Summary
Teva Pharmaceutical Industries recently presented positive results from its Phase 3 SPACE study evaluating AJOVY® (fremanezumab) for preventing episodic migraine in children and adolescents aged 6-17 years. The trial demonstrated that AJOVY significantly reduced monthly migraine days and monthly headache days compared to placebo over a 12-week period. Results showed a reduction of 2.5 monthly migraine days in the AJOVY group compared to 1.4 in the placebo group, and 2.6 versus 1.5 monthly headache days, with a higher percentage of patients achieving a 50% response rate.
The study confirmed that the efficacy and safety profile seen in adults also applies to the pediatric population, with consistent benefits across different age groups and sexes. No new safety concerns were observed, marking AJOVY as a promising treatment option for young patients with episodic migraine. This milestone provides hope for improved care for children and adolescents facing the challenges of migraine.
Read Announcement
duvakitug - FDA Regulatory Timeline and Events
duvakitug is a drug developed by Teva Pharmaceutical Industries for the following indication: for the treatment of moderate-to-severe inflammatory bowel disease (IBD).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- duvakitug
- Announced Date:
- February 18, 2025
- Indication:
- for the treatment of moderate-to-severe inflammatory bowel disease (IBD).
Announcement
Teva Pharmaceutical announced that it will conduct a conference call and live webcast at 8 am E.T. on Monday, February 24, 2025. During the conference call, Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer, and external IBD key opinion leaders (KOLs) will discuss new data presented for duvakitug (anti-TL1A) positive Phase 2b results at the 20th Annual Congress of the European Crohn's and Colitis Organization (ECCO).
AI Summary
Teva Pharmaceutical Industries Ltd. announced that it will host a conference call and live webcast on Monday, February 24, 2025, at 8 am Eastern Time. During this event, Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer, along with external IBD key opinion leaders, will discuss the recently presented positive Phase 2b results for duvakitug (anti-TL1A). These encouraging data were shared at the 20th Annual Congress of the European Crohn’s and Colitis Organization (ECCO).
Interested participants are encouraged to register in advance to receive a local or toll-free phone number and their personal pin. A live webcast of the event will be available on Teva’s website, with a replay provided 24 hours after the call for those who are unable to attend live.
Read Announcement- Drug:
- duvakitug
- Announced Date:
- December 17, 2024
- Indication:
- for the treatment of moderate-to-severe inflammatory bowel disease (IBD).
Announcement
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Sanofi announce that the Phase 2b RELIEVE UCCD study met its primary endpoints in patients with ulcerative colitis (UC) and Crohn's disease (CD). RELIEVE UCCD investigated duvakitug (TEV'574/SAR447189), a human IgG1-λ2 monoclonal antibody targeting TL1A, for the treatment of moderate-to-severe inflammatory bowel disease (IBD).
AI Summary
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., and Sanofi have announced positive results from the Phase 2b RELIEVE UCCD study. This study focused on patients with moderate-to-severe inflammatory bowel disease, including both ulcerative colitis (UC) and Crohn’s disease (CD). The trial tested duvakitug (TEV'574/SAR447189), a human IgG1-λ2 monoclonal antibody designed to target TL1A. Researchers reported that the study met its primary endpoints, showing promise for the drug's ability to address key symptoms and underlying inflammation in these patients. The achievement marks an important step forward in the development of new treatments for IBD, potentially offering a novel option for those who have not responded well to current therapies.
Read Announcement
risperidone - FDA Regulatory Timeline and Events
risperidone is a drug developed by Teva Pharmaceutical Industries for the following indication: Injectable suspension, for subcutaneous use, is indicated for the treatment of schizophrenia in adults.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- risperidone
- Announced Date:
- May 30, 2025
- Indication:
- Injectable suspension, for subcutaneous use, is indicated for the treatment of schizophrenia in adults
Announcement
Teva Pharmaceuticals announced the presentation of real-world clinical outcomes, treatment patterns and healthcare resource utilization (HCRU) data evaluating UZEDY® (risperidone), an extended-release injectable suspension of risperidone for subcutaneous use every one or two months for the treatment of schizophrenia in adults, versus second-generation daily oral options.
AI Summary
Teva Pharmaceuticals has presented new real-world data evaluating UZEDY® (risperidone) extended‐release injectable suspension, which is used every one or two months in adults with schizophrenia. The study compared UZEDY with daily oral second-generation antipsychotic options and found that patients on UZEDY experienced fewer relapses and a longer time before a relapse occurred. Additionally, these patients showed improved adherence and persistence with their treatment regimen.
The findings also revealed that UZEDY users had fewer inpatient hospital stays, outpatient visits, and emergency department trips, resulting in lower overall healthcare resource utilization. This data suggests that UZEDY could offer a more effective treatment alternative for individuals who have difficulty following daily medication schedules, possibly reducing hospital visits and overall healthcare costs.
Read Announcement- Drug:
- risperidone
- Announced Date:
- February 25, 2025
- Indication:
- Injectable suspension, for subcutaneous use, is indicated for the treatment of schizophrenia in adults
Announcement
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. announced that the supplemental New Drug Application (sNDA) for UZEDY extended-release injectable suspension for the maintenance treatment of BP-I in adults has been accepted for filing by the U.S. Food and Drug Administration (FDA).
AI Summary
Teva Pharmaceuticals announced that the supplemental New Drug Application (sNDA) for UZEDY extended-release injectable suspension for the maintenance treatment of bipolar I disorder (BP-I) in adults has been accepted for filing by the U.S. Food and Drug Administration (FDA). This filing leverages existing clinical data from prior risperidone formulations and builds on the Agency’s previous findings related to safety and efficacy. The submission marks an important step toward expanding UZEDY’s potential beyond its current approval for treating schizophrenia, and it demonstrates Teva’s commitment to addressing the unmet needs of patients with BP-I. Teva will lead the regulatory process, and Medincell is eligible for royalties on net sales, underscoring the collaborative effort to provide new long-acting injectable options that may help improve treatment adherence and enhance the management of complex mental health conditions.
Read Announcement- Drug:
- risperidone
- Announced Date:
- September 23, 2024
- Indication:
- Injectable suspension, for subcutaneous use, is indicated for the treatment of schizophrenia in adults
Announcement
Teva Pharmaceuticals today presented data informing clinical strategies for switching patients to UZEDY®, an extended-release injectable suspension of risperidone for subcutaneous use every one or two months for the treatment of schizophrenia in adults, from a once-monthly subcutaneous injection of Perseris® (RBP-7000).
AI Summary
Teva Pharmaceuticals recently presented new data that guides how to switch patients with schizophrenia from a once‐monthly subcutaneous injection of Perseris® (RBP‑7000) to UZEDY®, an extended‑release injectable suspension of risperidone. UZEDY® is designed to be administered subcutaneously every one or two months, potentially offering a more convenient treatment schedule. This study outlines practical clinical strategies that can help doctors transition patients smoothly to UZEDY®, aiming to maintain consistent therapeutic effects while reducing injection frequency. The data provide insights into dosing and administration techniques that may enhance patient adherence and overall comfort with treatment. Teva’s findings contribute to the understanding of how different injection schedules can be used effectively, which might improve long‑term management of schizophrenia. Additional studies and further clinical discussions are expected to continue refining these treatment approaches.
Read Announcement- Drug:
- risperidone
- Announced Date:
- June 1, 2024
- Indication:
- Injectable suspension, for subcutaneous use, is indicated for the treatment of schizophrenia in adults
Announcement
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA),today announced the presentation of seven studies from its long-acting injectable (LAI) schizophrenia research program.
AI Summary
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., recently presented seven studies from its long-acting injectable (LAI) schizophrenia research program. The studies offer new insights into switching patients from a once-monthly intramuscular injection of paliperidone palmitate to UZEDY, a subcutaneous formulation of risperidone. According to the population pharmacokinetic analysis, switching to UZEDY four weeks after the last dose of paliperidone palmitate provides a comparable profile, with similar active moiety levels. UZEDY is designed to be administered every one or two months, without requiring an initial loading dose or oral supplementation. The findings address a current gap in clinical data regarding transitions between LAI options. These insights are expected to help healthcare providers optimize treatment strategies for schizophrenia patients and were presented at the Psych Congress Elevate 2024 Annual Meeting in Las Vegas.
Read Announcement- Drug:
- risperidone
- Announced Date:
- April 6, 2024
- Indication:
- Injectable suspension, for subcutaneous use, is indicated for the treatment of schizophrenia in adults
Announcement
Teva Pharmaceuticals announced the presentation of eight studies from its LAI schizophrenia research program, including data evaluating UZEDY, an extended-release injectable suspension of risperidone for subcutaneous use every one or two months for the treatment of schizophrenia in adults.
AI Summary
Teva Pharmaceuticals recently presented eight studies from its long-acting injectable (LAI) schizophrenia research program at the 2024 Schizophrenia International Research Society Congress. A key focus of the presentation was on UZEDY, an extended-release injectable suspension of risperidone designed for subcutaneous use every one or two months to treat schizophrenia in adults. Data from these studies, including population pharmacokinetic modeling, suggest that switching patients from an intramuscular LAI formulation of risperidone microspheres to UZEDY—ideally 4-6 weeks after the last dose—can achieve comparable drug exposure. This flexible dosing option may help improve treatment adherence, lower relapse rates, and reduce hospitalizations by offering tailored dosing strategies that address individual patient needs.
Read Announcement
TEV-53408 - FDA Regulatory Timeline and Events
TEV-53408 is a drug developed by Teva Pharmaceutical Industries for the following indication: In adults with celiac disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TEV-53408
- Announced Date:
- May 27, 2025
- Indication:
- In adults with celiac disease
Announcement
Teva Pharmaceutical announced that the US Food and Drug Administration (FDA) granted Fast Track designation for investigational TEV-53408, an anti-IL-15 antibody, for the treatment of people with celiac disease on a gluten-free diet.
Read Announcement
TEV-749 - FDA Regulatory Timeline and Events
TEV-749 is a drug developed by Teva Pharmaceutical Industries for the following indication: In adult patients with schizophrenia.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TEV-749
- Announced Date:
- March 31, 2025
- Indication:
- In adult patients with schizophrenia
Announcement
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. announced the presentation of a patient and healthcare professional (HCP) attitudes and experiences survey study, complementing the successful Phase 3 Subcutaneous Olanzapine Extended-Release Injection Study (SOLARIS) evaluating TEV-'749.
AI Summary
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., presented a survey study examining attitudes and experiences from both patients and healthcare professionals (HCPs) regarding TEV-'749. This study complements the successful Phase 3 SOLARIS trial of the subcutaneous olanzapine extended-release injection. The survey revealed that over 92% of patients, along with 87% of nurses and 72% of physicians, were satisfied or very satisfied with the treatment regimen, including the initiation process, monthly dosing schedule, and overall drug experience. The findings highlight a strong preference for the subcutaneous injection format, with many participants favoring features such as a simplified initiation regimen and the absence of a lengthy post-injection monitoring period. These results underscore Teva’s commitment to developing innovative treatment options that address key challenges faced by individuals living with schizophrenia.
Read Announcement- Drug:
- TEV-749
- Announced Date:
- September 21, 2024
- Indication:
- In adult patients with schizophrenia
Announcement
Teva Pharmaceuticals, announced new positive efficacy, safety and tolerability results for Phase 3 Subcutaneous Olanzapine Extended-Release Injection Study (SOLARIS) trial evaluating TEV-‘749 in adult patients diagnosed with schizophrenia.
AI Summary
Teva Pharmaceuticals announced positive results from the Phase 3 SOLARIS trial evaluating TEV-‘749, a new subcutaneous extended-release olanzapine injection for adults with schizophrenia. The study met its primary endpoint by showing significant improvements in the Positive and Negative Syndrome Scale (PANSS) score from baseline to week 8. Key secondary endpoints also showed improvements as measured by the Clinical Global Impression-Severity (CGI-S) and Personal and Social Performance (PSP) scales. Researchers highlighted that, unlike existing long-acting olanzapine treatments, TEV-‘749 exhibited no cases of post-injection delirium/sedation syndrome (PDSS) in study participants, addressing a major safety concern associated with current options. These promising results suggest that TEV-‘749 could offer an effective and safer alternative for managing schizophrenia symptoms while eliminating the PDSS risk inherent in other long-acting olanzapine products.
Read Announcement- Drug:
- TEV-749
- Announced Date:
- May 8, 2024
- Indication:
- In adult patients with schizophrenia
Announcement
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. announced results from the efficacy portion of the Phase 3 Subcutaneous OLAnzapine extended-Release Injection Study (SOLARIS) trial evaluating TEV-‘749 in adult patients with schizophrenia compared to placebo.
Read Announcement
TVB-009P - FDA Regulatory Timeline and Events
TVB-009P is a drug developed by Teva Pharmaceutical Industries for the following indication: For postmenopausal osteoporosis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TVB-009P
- Announced Date:
- October 8, 2024
- Indication:
- For postmenopausal osteoporosis.
Announcement
Teva Pharmaceutical Industries Ltd. announced that the United States (U.S.) Food and Drug Administration (FDA) has accepted, and the European Medicines Agency (EMA) has validated, applications for TVB-009P, a biosimilar candidate to Prolia® (denosumab).1
AI Summary
Teva Pharmaceutical Industries announced that the U.S. Food and Drug Administration (FDA) has accepted and the European Medicines Agency (EMA) has validated its applications for TVB-009P, a biosimilar candidate to Prolia® (denosumab). The U.S. Biologics License Application (BLA) seeks to establish interchangeability, while the European Marketing Authorization Application (MAA) covers all indications approved for Prolia, including treatment for conditions that increase fracture risk, such as postmenopausal osteoporosis. The submissions are supported by comprehensive analytical and clinical data, including results from a Phase 3 trial that compared TVB-009P with Prolia in women with postmenopausal osteoporosis. Both agencies are expected to deliver their decisions or opinions during the second half of 2025. This move marks an important step for Teva’s expanding biosimilar portfolio, reinforcing its commitment to providing more accessible treatment options for patients globally.
Read Announcement
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