https://animedix.com/news/pdufa-calendar/29518b83-d969-44e3-b608-cdb33af94d59
Gedatolisib PDUFA Date — Celcuity
FDA PDUFA decision date for Gedatolisib is July 17, 2026. Developed by Celcuity. Indication: HR+/HER2- PIK3CA wildtype advanced breast cancer. Current status:...
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https://www.clinuvel.com/2019/10/fda-clarifies-scenesse-pdufa-date/
FDA Clarifies SCENESSE® PDUFA Date - CLINUVEL
Oct 2, 2019 - CLINUVEL PHARMACEUTICALS LTD today announced that the US Food and Drug Administration (FDA) has notified the company that the Prescription Drug User Fee Act...
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https://www.biopharmawatch.com/company/NCEL
NCEL (NewcelX Ltd.) PDUFA Date | FDA Catalyst & Approval Status
NewcelX (NCEL) catalyst timeline: 256 past events since 2021 with dates and sources. Upcoming PDUFA dates, pipeline and insider trades.
pdufa datencelltdfdacatalyst
https://animedix.com/news/pdufa-calendar/2b2a73c1-ca92-4856-a5c4-d6c103f9e954
Linvoseltamab PDUFA Date — Regeneron Pharmaceuticals
FDA PDUFA decision date for Linvoseltamab is July 10, 2025. Developed by Regeneron Pharmaceuticals. Indication: Relapsed/refractory multiple myeloma. Current...
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https://animedix.com/news/pdufa-calendar/01ace33a-0d63-4070-a5f1-a815bf1fb495
Cytisinicline PDUFA Date — Achieve Life Sciences
FDA PDUFA decision date for Cytisinicline is June 20, 2026. Developed by Achieve Life Sciences. Indication: Nicotine dependence / smoking cessation. Current...
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https://www.cgtlive.com/view/b-vec-pdufa-date-extended-to-may-2023
B-VEC PDUFA Date Extended to May 2023 | CGTlive®
Oct 12, 2026 - The FDA made the decision in response to manufacturing process information that it considered a major amendment.
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