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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 FDA's Oncologic Drugs Advisory Committee has casted their votes on the utilization of certain treatments in the multiple ...
GSK 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 ...
FDA panel rejects GSK's Blenrep combo due to severe ocular toxicity and dosing concerns in multiple myeloma trials ahead of ...
The panelists flagged safety concerns with Blenrep and GSK’s failure to optimize its dosing regimen for the antibody-drug ...
An FDA advisory committee ruled in two separate votes that two belantamab mafodotin combination regimens should not be used in the proposed dosages for previously treated adult patients with ...
The U.S. FDA's panel of independent advisers on Thursday recommended against GSK's blood cancer drug Blenrep, citing concerns ...
The pharmaceutical company said it remained confident in the benefit and risk profile of Blenrep and will continue to work ...
On a quest to bring its multiple myeloma antibody-drug conjugate (ADC) Blenrep back to the U.S. | Members of the FDA's Oncologic Drugs Advisory Committee voiced concerns with ocular toxicity side ...
FDA advisers on Thursday voted against GSK's blood cancer drug Blenrep, finding that its risks outweighed its benefits at the ...