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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 ....

Priya Singhal , European Medicines Agency , Regulatory Sciences , Drug Administration , Biogen Inc , More Such Health News , Marketing Authorization Application , New England Journal , Priority Review , Prescription Drug User Fee Act , Global Safety , Interim Head ,

Navigate the complexities of cell and gene therapies

BioPharma ....

Cardinal Health Regulatory Sciences , Regulatory Sciences , Investigational New Drug , Gene Therapy ,

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. ....

Deric Dube , Priya Singhal , Regulatory Sciences , Drug Administration , Priority Review , New Drug Application , Prescription Drug User Fee Act , Travere Therapeutics , Risk Evaluation Mitigation Strategy , Global Safety , Interim Head ,

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 ....

United Kingdom , Priya Singhal , Mike Hencke , Edan Haro , Walter Gilbert , Charles Weissmann , Heinz Schaller , Kenneth Murray , Ionis Pharmaceuticals Inc , Regulatory Sciences , Drug Administration , Exchange Commission , Prescription Drug User Fee Act , Major Amendment , Global Safety , Interim Head , Ionis Pharmaceuticals , Amyotrophic Lateral Sclerosis , Continuous Commitment , Sir Kenneth Murray , Nobel Prize , Healthy Lives , Private Securities Litigation Reform Act , Neurol Neurosurg ,