Biogen (BIIB) and Sage Therapeutics (SAGE) announced the U.S. FDA has accepted the filing of a New Drug Application for zuranolone in the treatment of major depressive disorder and postpartum depression. Zuranolone is an investigational drug being evaluated as a 14-day, rapid-acting, once-daily, oral treatment in adults with MDD and PPD. The application has been granted priority review and the FDA has assigned a Prescription Drug User Fee Act action date of August 5, 2023.
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