The U.S. Food and Drug Administration (FDA) has accepted and given priority review designation to Biogen‘s application requesting the approval of aducanumab (BIIB037) for the treatment of Alzheimer’s disease. While the Prescription Drug User Fee Act (PDUFA) action date is set for March 7, 2021 — meaning a decision is due by then — the agency said it plans to act early on this application under an expedited review. An advisory committee meeting is in the FDA’s plans…
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