Biogen and Eisai have submitted a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) requesting the approval of aducanumab (BIIB037) for the treatment of Alzheimer’s disease. The submission, which was asking for priority review, had been pushed back earlier this year. The agency now has 60 days to decide whether to accept the BLA for review, and if accepted, whether it will be carried out under the FDA’s priority review program.…
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