28th Apr 2026 09:25
GSK PLC - London-based pharmaceuticals maker - Bepirovirsen, GSK's treatment for chronic hepatitis B, is accepted for priority review and given 'breakthrough therapy designation' by the US Food & Drug Administration. GSK says the fast track approval process for its new drug application recognises bepirovirsen's potential for substantial improvement over existing treatments. Chronic hepatitis is a leading cause of liver cancer, and bepirovirsen, an investigational antisense oligonucleotide, showed "clinically meaningful functional cure rates" in phase III trials of adults. The FDA sets October 26 as its goal date for a decision on the drug application. Read More