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The British pharmaceutical company said combinations for its Blenrep drug were evaluated in adults with relapsed or ...
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 ...
Oncologic Drugs Advisory Committee has voted against two proposed combination regimens containing GSK’s Blenrep (belantamab ...
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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 ...
The panel expressed concerns about the proposed doses of Blenrep (belantamab mafodotin) in GSK's marketing application, ...
GSK remains confident in Blenrep’s safety and efficacy, and will work with the FDA as it reviews the drug, the company said ...
GSK has failed to win the backing of influential advisers to the US drugs regulator for a key blood cancer drug, putting its ...
The pharmaceutical company said it remained confident in the benefit and risk profile of Blenrep and will continue to work ...
The British drugmaker was trying to revive the drug, which was pulled from U.S. markets in 2022 after failing a late-stage ...
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