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Pharmaceutical Technology on MSNGSK’s Blenrep faces setback as FDA cancer committee votes against approvalThe US Food and Drug Administration’s (FDA’s) Oncologic Drugs Advisory Committee (ODAC) has voted against the benefit/risk ...
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 ...
FDA advisers on Thursday voted against GSK's blood cancer drug Blenrep, finding that its risks outweighed its benefits at the ...
The pharmaceutical company said it remained confident in the benefit and risk profile of Blenrep and will continue to work ...
The panel expressed concerns about the proposed doses of Blenrep (belantamab mafodotin) in GSK's marketing application, ...
An FDA advisory committee ruled in two separate votes that two belantamab mafodotin combination regimens should not be used ...
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 ...
SALES FORECAST: The U.K. pharmaceutical company is expected to report sales of 7.8 billion pounds ($10.42 billion), according to consensus estimates compiled by the company. For last year's second ...
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.
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 ...
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