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The British pharmaceutical company said combinations for its Blenrep drug were evaluated in adults with relapsed or ...
GSK Plc’s blood cancer drug failed to secure the backing of a panel of US regulatory advisers, putting its approval in doubt.
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.
The panelists flagged safety concerns with Blenrep and GSK’s failure to optimize its dosing regimen for the antibody-drug ...
Despite the setback with the Oncologic Drugs Advisory Committee vote, GSK emphasizes the unmet need in multiple myeloma and ...
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 ...
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Zacks.com on MSNFDA Advisory Panel Votes Against Approval of GSK's Blenrep ComboGSK plc GSK announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted against the overall benefit/risk profile of the Blenrep (belantamab mafodotin-blmf) combination therapy at the ...
GSK shares fell more than 6% on Friday after a U.S. FDA advisory panel recommended against approving its blood cancer drug ...
The panel expressed concerns about the proposed doses of Blenrep (belantamab mafodotin) in GSK's marketing application, ...
FDA panel rejects GSK's Blenrep combo due to severe ocular toxicity and dosing concerns in multiple myeloma trials ahead of ...
The pharmaceutical company said it remained confident in the benefit and risk profile of Blenrep and will continue to work ...
GSK has failed to win the backing of influential advisers to the US drugs regulator for a key blood cancer drug, putting its ...
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