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GSK, FDA and Blenrep drug

The Wall Street Journal on MSN · 14h

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.

Benzinga · 55m

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.

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, ...

3h

FDA approves GSK’s prefilled syringe presentation of Shingrix

Administering Shingrix previously required combining a lyophilised antigen with a liquid adjuvant from two separate vials.

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 ...

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 ...

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