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News

FDA, GSK and Cancer Drug

The Wall Street Journal on MSN · 15m
GSK Shares Drop After FDA Committee Vote Leaves Cancer-Drug Comeback in Doubt
The pharmaceutical company said it remained confident in the benefit and risk profile of Blenrep and will continue to work with the FDA.
Benzinga · 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.
Bloomberg on MSN · 5h
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.
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, ...
16hon MSN
GSK's blood cancer drug fails to secure US FDA advisers' support
The U.S. FDA's panel of independent advisers on Thursday recommended against GSK's blood cancer drug Blenrep, citing concerns ...
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 ...

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