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CAMBRIDGE, Mass., Dec. 22, 2021Inc. (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today announced that the First Committee on New Drugs (NDC) of the Pharmaceutical Affairs and Food Sanitation Council
Biogen to seek re-examination following CHMP negative opinion for aducanumabCAMBRIDGE, Mass., Dec. 17, 2021Inc. (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today announced that the Committee for
Message : Required fields TOKYO, July 29, 2021 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Michel Vounatsos, "Biogen") today announced results of a longitudinal preliminary assessment of the clinical effects of lecanemab (development code: BAN2401) — granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) in June 2021 — following 18 months of treatment in the open-label extension (OLE) of the Phase 2b proof-of-concept study in subjects ...
Biogen Inc. Biogen and Eisai Announce FDA’s 3-Month Extension of Review Period for the Biologics License Application for Aducanumab Biogen and Eisai Announce FDA’s 3-Month Extension of Review Period for the Biologics License Application for Aducanumab The new Prescription Drug User Fee Act (PDUFA) action date set by the FDA is June 7, 2021 CAMBRIDGE, Mass. and TOKYO, Jan. 29, 2021 (GLOBE NEWSWIRE) -- Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period by three months for the Biologics Li...
(2) The new Prescription Drug User Fee Act (PDUFA) action date set by the FDA is June 7, 2021 CAMBRIDGE, Mass. and TOKYO, Jan. 29, 2021 (GLOBE NEWSWIRE) -- Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period by three months for the Biologics License Application (BLA) for aducanumab, an investigational treatment for Alzheimer's disease. The updated Prescription Drug User Fee Act (PDUFA) action date is June 7, 2021. As part of the ongoing review, Biogen submitted a response to an information r...