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STAT57m
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 ...
Applied Clinical Trials Online36m
ODAC Votes Against Risk-Benefit Profile of GSK’s Blenrep Combinations in Relapsed/Refractory Multiple Myeloma
Despite the setback with the Oncologic Drugs Advisory Committee vote, GSK emphasizes the unmet need in multiple myeloma and ...
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, ...
BioSpace4h
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 ...
Fierce Pharma3d
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 ...
GSK seeks FDA nod for expanded use of RSV vaccine in adults
British drugmaker GSK said on Monday it had submitted an application to the U.S. Food and Drug Administration to extend the ...