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GSK, food and drug administration and FDA Committee

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.

STAT · 1h

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

Reuters on MSN · 2h

GSK falls as blood cancer drug likely headed for US rejection

GSK shares fell more than 6% on Friday to the bottom of Britain's blue-chip index after a U.S. FDA advisory panel recommended against approving its blood cancer drug Blenrep, citing earlier concerns over side effects.

pharmaphorum1h

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, ...

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.

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 ...

NDTV Profit9h

GSK Blood Cancer Drug Blenrep Fails To Win FDA Panel Support

GSK remains confident in Blenrep’s safety and efficacy, and will work with the FDA as it reviews the drug, the company said ...

Becker's Hospital Review1d

FDA to review myeloma drug after mixed trial data, eye safety concerns

The FDA is reevaluating GlaxoSmithKline’s blood cancer drug Blenrep following mixed results from two phase 3 trials and mounting concerns about eye-related side effects and dosing. The agency is ...

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