The U.S. is cutting the Hepatitis B vaccine from its recommended list. But here's a place where the medical establishment — ...
GSK plc GSK announced positive results from two phase III studies, B-Well 1 and B-Well 2, which evaluated its investigational ...
GSK will be filing for approval of bepirovirsen in hepatitis B to global regulatory authorities based on the Phase III data.
The companies didn’t provide details, but said global regulatory filings are now planned for the therapy, an oligonucleotide meant to provide “functional cures” for chronic hepatitis B infections.
Though specific data for bepirovirsen remain under wraps, GSK plans to file for approval in the first quarter of 2026.
GSK will use promising results from two studies of its experimental chronic hepatitis B therapy to support planned regulatory ...
GSK’s potential “functional cure” for hepatitis B drug has proven its worth in a pair of hotly anticipated phase 3 studies, setting up the pharma for a push to the FDA.
GSK's experimental drug to treat chronic hepatitis B infection met the main goal in two closely watched studies, the drugmaker said on Wednesday, bringing a functional cure a step closer for over 250 ...
Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration. She was previously a medical devices reporter. You can reach Lizzy on Signal at lizzylaw.53. Helen Branswell covers issues ...