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The pharmaceutical company said it remained confident in the benefit and risk profile of Blenrep and will continue to work ...
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 ...
GSK shares fell more than 6% on Friday after a U.S. FDA advisory panel recommended against approving its blood cancer drug ...
GSK has failed to win the backing of influential advisers to the US drugs regulator for a key blood cancer drug, putting its ...
GSK Plc shares tumbled after its blood cancer drug failed to secure the backing of a panel of US regulatory advisers, putting ...
Administering Shingrix previously required combining a lyophilised antigen with a liquid adjuvant from two separate vials.
FDA panel rejects GSK's Blenrep combo due to severe ocular toxicity and dosing concerns in multiple myeloma trials ahead of ...
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 ...
In a surprise, a FDA advisory panel voted that risks tied to a GSK blood cancer drug called Blenrep outweighed the benefits ...
The panelists flagged safety concerns with Blenrep and GSK’s failure to optimize its dosing regimen for the antibody-drug ...
The FDA’s Oncologic Drugs Advisory Committee has voted against the benefit/risk profile of GSK’s Blenrep just days before the drug’s PDUFA date.
GSK remains confident in Blenrep’s safety and efficacy, and will work with the FDA as it reviews the drug, the company said ...