Posted by Michael Wonder on 28 Apr 2026
Bepirovirsen accepted for priority review and granted breakthrough therapy designation by the US FDA
28 April 2026 - 26 October 2026 assigned by FDA as PDUFA date.
GSK today announced that the US FDA has accepted for priority review a new drug application for bepirovirsen, an investigational antisense oligonucleotide, for the treatment of adults with chronic hepatitis B.
