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News

FDA, GSK and Cancer Drug

Bloomberg on MSN · 2d
GSK Blood Cancer Drug Blenrep Fails to Win FDA Panel Support
GSK Plc’s blood cancer drug failed to secure the backing of a panel of US regulatory advisers, putting its approval in doubt.
Medical Dialogues · 7h
GSK fails to gain FDA advisers backing for cancer therapy
GSK plc has announced that the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted against the overall benefit/risk profile at the proposed dosage of
STAT · 2d
FDA advisers say risks of GSK blood cancer drug outweigh benefits in surprise setback
FDA advisers on Thursday voted against GSK's blood cancer drug Blenrep, finding that its risks outweighed its benefits at the selected dose
Fierce Pharma
2d
FDA advisors spurn GSK's Blenrep comeback dreams on safety, trial concerns
On a quest to bring its multiple myeloma antibody-drug conjugate Blenrep back to the U.S. | Members of the FDA's Oncologic ...
pharmaphorum
2d
GSK's growth plans dented by Blenrep setback
The panel expressed concerns about the proposed doses of Blenrep (belantamab mafodotin) in GSK's marketing application, ...
STAT
1d
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 ...

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