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GSK says FDA accepts bepirovirsen NDA for priority review in chronic hepatitis B

PUBT·04/28/2026 06:14:12
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GSK says FDA accepts bepirovirsen NDA for priority review in chronic hepatitis B
  • FDA accepted GSK bepirovirsen New Drug Application for priority review in adults with chronic hepatitis B.
  • Bepirovirsen received Breakthrough Therapy Designation, adding to Fast Track status granted in February 2024.
  • FDA set a PDUFA goal date of Oct. 26, 2026.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. GSK plc published the original content used to generate this news brief on April 28, 2026, and is solely responsible for the information contained therein.