Just when the future looked bleak for GSK’s Blenrep comeback in the U.S., the FDA has blessed the company's multiple myeloma ...

The U.S. Food and Drug Administration has extended its review of GSK's blood cancer drug, Blenrep, as a combination treatment, the company said on Wednesday.

The FDA on Tuesday rejected a skin therapy from Replimune Group, suggesting a hardened stance on drug approvals under new agency officials ...

The agency also revoked Sarepta's platform technology designation for AAVrh74 Friday and issued a safety communication saying ...

While Sarepta has now consented to the FDA’s request to stop selling Elevidys, the company’s brief standoff with the agency ...

Roche and Genentech were unable to sufficiently demonstrate the benefit of using Columvi in an earlier treatment setting for ...

The FDA has declined to approve Columvi, in combination with the chemo regimen GemOx, for the treatment of second-line DLBCL ...

GSK plc GSK announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted against the overall benefit/risk profile of the Blenrep (belantamab mafodotin-blmf) combination therapy at the ...

GSK shares sink after FDA panel rejects Blenrep cancer drug, raising doubts over turnaround strategy. GSK (LSE: GSK) investors took a sharp knock on Friday after its much-hyped blood cancer drug, ...

GSK shares fell more than 6% on Friday to the bottom of Britain's blue-chip index after a U.S. FDA advisory panel recommended ...

(Reuters) -GSK shares fell more than 6% on Friday after a U.S. FDA advisory panel recommended against approving its blood ...

A group of independent advisors to the U.S. Food and Drug Administration (FDA) on Thursday voted against the approval of a combination drug regimen involving GSK’s (NYSE:GSK) blood cancer medicine ...