The rough ride presaged by briefing documents came to pass for GSK plc with the drug first approved by the U.S. FDA as Blenrep (belantamab mafodotin, bel-maf), as the agency’s Oncologic Drugs Advisory ...

GSK provides update on US FDA advisory committee review of Blenrep (belantamab mafodotin-blmf) combinations for patients with relapsed/refractory multiple myeloma GSK plc (LSE/NYSE: GSK) notes that ...

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 advisors have voted that the benefit/risk profile of GSK's multiple myeloma therapy, Blenrep, does not support its approval in the US – denting the prospects of one of the company's top growth ...

GSK’s plan to bring blood cancer drug Blenrep (belantamab mafodotin) back to markets has hit a stumbling block, after the US Food and Drug Administration (FDA) identified eye safety concerns ahead of ...

The U.S. FDA’s Oncologic Drugs Advisory Committee took up the matter of GSK plc’s relapsed/refractory multiple myeloma drug, Blenrep (belantamab mafodotin). A B-cell maturation antigen-directed ...

The new Prescription Drug User Fee Act (PDUFA) action date is Oct. 23, which allows the FDA to review additional information provided in support of the application. The BLA is supported by efficacy ...