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GSK, FDA and Blenrep drug

Benzinga · 26m

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.

The Wall Street Journal on MSN · 13h

FDA Committee Votes Against GSK Blood Cancer Drug Blenrep

The British pharmaceutical company said combinations for its Blenrep drug were evaluated in adults with relapsed or refractory multiple myeloma who have previously received at least one line of therapy.

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

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 Pharma2d

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 ...

GlobalData on MSN1d

GSK’s Blenrep US comeback hindered by eye safety concerns

FDA reviewers have identified high rates of ocular toxicity as GSK looks to place its blood cancer drug back on the market.

The Pharma Letter1d

FDA probes ocular toxicity of Blenrep as GSK seeks new indications

UK pharma major GSK is seeking US approval for Blenrep (belantamab mafodotin) in two multiple myeloma indications.

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