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Biogen s Tofersen MAA Accepted In Europe To Treat Rare, Genetic Form Of ALS

WESTON (dpa-AFX) - Biogen Inc. (BIIB) announced Monday that the European Medicines Agency or EMA has accepted the Marketing Authorization Application or MAA for review of tofersen to treat rare

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Navigate the complexities of cell and gene therapies

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FDA Needs Additional Time to Review Sparsentan, Tofersen Applications

The Food and Drug Administration (FDA) has extended the review periods for 2 investigational products: sparsentan and tofersen.

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Biogen (BIIB) Announces FDA s 3-Month Extension of Review Period for NDA for Tofersen

Biogen (BIIB) Announces FDA s 3-Month Extension of Review Period for NDA for Tofersen
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Biogen Inc : Biogen Announces FDA s 3-Month Extension of Review Period for the New Drug Application for Tofersen

The new Prescription Drug User Fee Act (PDUFA) action date set by the FDA is April 25, 2023 CAMBRIDGE, Mass., Oct. 17, 2022Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration

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