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News

GSK, FDA and Blenrep

Digest more
 · 1h
GSK's Blood Cancer Drug Faces US Setback Due To FDA Panel's Eye Safety Warning
FDA panel rejects GSK's Blenrep combo due to severe ocular toxicity and dosing concerns in multiple myeloma trials ahead of July 23 PDUFA decision.

Continue reading

 · 5h · on MSN
GSK’s Blood Cancer Drug Blenrep Fails to Win FDA Panel Support
 · 14h · on MSN
FDA Committee Votes Against GSK Blood Cancer Drug Blenrep
pharmaphorum
3h
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, ...
Fierce Pharma
2d
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 ...
5h
FDA votes against overall benefit/risk profile of GSK's multiple myeloma candidate at proposed dosage
Drugmaker GSK said on Friday that the US Food and Drug Administration's Oncologic Drugs Advisory Committee had voted against ...

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