News

STAT47m
Pharmalittle: We’re reading about a GSK setback, another Sarepta gene therapy death, and more
In a surprise, a FDA advisory panel voted that risks tied to a GSK blood cancer drug called Blenrep outweighed the benefits ...
Pulmonology Advisor32m
FDA to Review Arexvy for 18 to 49-Year-Olds at Increased RSV Disease Risk
The FDA has accepted for review the sBLA to expand the indication of Arexvy (RSV vaccine, adjuvanted) to adults aged 18 to 49 years who are at increased risk.
Global Stocks in the Spotlight: Alibaba, Saab, Burberry, GSK
The Swedish defense company posted better-than-expected earnings and [raised its annual sales guidance]( ...
BioSpace1h
GSK’s Blenrep Loses Adcomm Vote, Further Clouding Comeback Bid
The panelists flagged safety concerns with Blenrep and GSK’s failure to optimize its dosing regimen for the antibody-drug ...
US FDA approves pre-filled version of GSK's shingles vaccine
The U.S. Food and Drug Administration approved a pre-filled syringe version of GSK's blockbuster shingles vaccine Shingrix, ...
Fierce Pharma2d
As GSK eyes Blenrep's US return, FDA flags eye safety concerns ahead of advisory committee meeting
GSK has been enjoying regulatory momentum in recent months as it works to bring its antibody-drug conjugate (ADC) Blenrep ...