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MRK, Daiichi's BLA for ADC drug gets FDA priority tag in lung cancer

Merck MRK and its Japanese partner Daiichi Sankyo announced that the FDA has accepted the biologics license application (BLA) ...

FDA Accepts Ultragenyx (RARE) BLA for Sanfilippo Syndrome Gene Therapy UX111

Ultragenyx (NASDAQ:RARE) is one of the 10 Overlooked Growth Stocks to Buy Now.

Replimune Gets Second FDA CRL for Melanoma Drug BLA, Stock Crashes

REPL stock plunges after a second FDA CRL delays RP1 melanoma approval, casting doubt on its regulatory path and near-term growth plans.
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Pierre Fabre Pharmaceuticals Announces Transfer from Atara Biotherapeutics of the Biologics License Application (BLA) for Tabelecleucel as Treatment of Epstein-Barr Virus ...

Tabelecleucel BLA currently under U.S. Food and Drug Administration (FDA) Priority Review as potentially the first approved therapy in the U.S. for EBV+ PTLD with a Prescription Drug User Fee Act ...

Ultragenyx Announces U.S. FDA Acceptance of BLA Resubmission for UX111 AAV Gene Therapy to Treat Sanfilippo Syndrome Type A (MPS IIIA)

If approved, UX111 will be the first approved therapy for the treatment of Sanfilippo syndrome Type A, a rare disease affecting young children ...
Cure Today

Linvoseltamab BLA Resubmission Accepted by FDA for Review

Linvoseltamab's BLA resubmission is under FDA review, with a decision anticipated by July 2025, supported by LINKER-MM1 trial data. The trial evaluates linvoseltamab's safety, tolerability, and ...