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GSK, FDA and Cancer Drug

Medical Dialogues · 22m

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

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· 1d · on MSN

GSK Blood Cancer Drug Blenrep Fails to Win FDA Panel Support

· 1d · on MSN

GSK falls as blood cancer drug likely headed for US rejection

Fierce Pharma2d

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 ...

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, ...

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 ...

Fierce Pharma4d

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 ...

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