logo
  

Sage Therapeutics: FDA To Review NDA For Zuranolone - Quick Facts

Sage Therapeutics, Inc. (SAGE) and Biogen Inc. (BIIB) announced the FDA has accepted the filing of a New Drug Application for zuranolone in the treatment of major depressive disorder and postpartum depression. The application has been granted priority review and the FDA has assigned a PDUFA action date of August 5, 2023.

Priya Singhal, Executive Vice President, Head of Development and Interim Head of Research and Global Safety and Regulatory Sciences at Biogen, said: "The FDA filing acceptance and granting of priority review are important milestones in the mission Biogen and our collaboration partner Sage share to advance the understanding and treatment of depression."

For More Such Health News, visit rttnews.com.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Ford Motor Co. has once again raised the price of its popular F-150 Lightning electric pickup truck after the automaker resumed its production that was halted following electric vehicle battery fire incident. The company will also resume shipments of the Lightning this week, reports said. Paducah, Kentucky-based Higdon Outdoors LLC is recalling certain battery packs and replacement batteries citing fire and/or burn hazards, the U.S. Consumer Product Safety Commission said. The recall includes lithium-ion battery packs and replacement batteries on XS Series Pulsators, Swimmers, Crazy Kicker, and Flasher motion decoys used for waterfowl hunting. New York-based Delta Enterprise Corp. is recalling about 43,380 units of 2-in-1 outdoor kids swings citing fall hazard, the U.S. Consumer Product Safety Commission said. This recall involves 2-in-1 Outdoor Kids Swing with model numbers SW86508MM, SW86516MN, SW86575MM, SW86576MN and SW86577PW.
RELATED NEWS
Follow RTT