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GSK’s Blenrep faces setback as FDA cancer committee votes against approval
Oncologic Drugs Advisory Committee (ODAC) has voted against the benefit/risk profile of GSK’s Blenrep (belantamab mafodotin) just days before the drug’s Prescription Drug User Fee Act (PDUFA) date. This marks a significant setback for the UK-based pharma company,
(Reuters) -GSK shares fell more than 6% on Friday to the bottom of Britain's blue-chip index after a U.S. FDA advisory panel ...
In a surprise, a FDA advisory panel voted that risks tied to a GSK blood cancer drug called Blenrep outweighed the benefits ...
The anemia treatment missed its main goal in a myelofibrosis study. Meanwhile, Blenrep's return to the U.S. market may have ...
The U.S. FDA has approved a prefilled syringe presentation of GSK plc’s SHINGRIX for the prevention of shingles.
The U.S. Food and Drug Administration approved a pre-filled syringe version of GSK's blockbuster shingles vaccine Shingrix, ...
FDA reviewers have identified high rates of ocular toxicity as GSK looks to place its blood cancer drug back on the market.
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