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Oncologic Drugs Advisory Committee (ODAC) has voted against the benefit/risk profile of GSK’s Blenrep (belantamab mafodotin) ...
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 Blenrep back to the U.S. | Members of the FDA's Oncologic ...
Oncologic Drugs Advisory Committee (ODAC) voted against the overall benefit/risk profile at the proposed dosage of GSK plc’s ...
The panel expressed concerns about the proposed doses of Blenrep (belantamab mafodotin) in GSK's marketing application, ...
FDA advisers on Thursday voted against GSK's blood cancer drug Blenrep, finding that its risks outweighed its benefits at the ...
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 Plc (NYSE:GSK) stock fell 5% after a U.S. Food and Drug Administration advisory panel voted against recommending approval for its blood cancer drug Blenrep, citing concerns that risks outweigh ...
Despite the setback with the Oncologic Drugs Advisory Committee vote, GSK emphasizes the unmet need in multiple myeloma and ...
"GSK remains confident in the benefit/risk profile of Blenrep and will continue to work closely with the FDA as they complete their review for Blenrep in patients with relapsed or refractory multiple ...
GSK’s blood cancer drug Blenrep has been reapproved by the EU medicines regulator after it was removed from sale in 2023 because a trial failed to show it was superior to other treatments.
In a surprise, a FDA advisory panel voted that risks tied to a GSK blood cancer drug called Blenrep outweighed the benefits ...