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News

FDA, GSK and Drug Administration

AOL · 1d
GSK's Blood Cancer Drug Faces US Setback Due To FDA Panel's Eye Safety Warning
Oncologic Drugs Advisory Committee (ODAC) voted against the overall benefit/risk profile at the proposed dosage of GSK plc’s (NYSE:GSK) Blenrep (belantamab mafodotin-blmf) combinations. The belantamab mafodotin combinations were evaluated in adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy.
The Wall Street Journal on MSN · 1d
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.
STAT · 1d
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
STAT
1d
Pharmalittle: We’re reading about a GSK setback, another Sarepta gene therapy death, and more
In a surprise, a FDA advisory panel voted that risks tied to a GSK blood cancer drug called Blenrep outweighed the benefits ...
GlobalData on MSN1d
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.

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