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/PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has extended by three months...
The U.S. Food and Drug Administration extended the review period by three months for Incyte's (INCY) application seeking extended approval of ruxolitinib cream (Opzelura) to...
Amryt Provides Update on Regulatory Review Process for Oleogel-S10 FDA PDUFA goal date extended by three months to February 28, 2022 EMA CHMP opinion now expected in January 2022 DUBLIN, Ireland, and ...
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...