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.
Published first on TheFly
See today’s best-performing stocks on TipRanks >>
Read More on BIIB:
- Biogen and Sage Therapeutics Announce FDA Accepts Filing of New Drug Application and Grants Priority Review of Zuranolone in the Treatment of Major Depressive Disorder and Postpartum Depression
- Eisai, Biogen say lecanemab received Priority Review status in Japan
- Lecanemab Receives Priority Review Status in Japan
- Marketing Authorization Application for Lecanemab as Treatment for Early Alzheimer’s Disease Accepted by European Medicines Agency
- Eisai, Biogen: EMA accepts MAA for lecanemab for early Alzheimer’s disease
