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The pharmaceutical company said it remained confident in the benefit and risk profile of Blenrep and will continue to work ...
Just when the future looked bleak for GSK’s Blenrep comeback in the U.S., the FDA has blessed the company's multiple myeloma ...
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Zacks Investment Research on MSNFDA Advisory Panel Votes Against Approval of GSK's Blenrep ComboGSK plc GSK announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted against the overall benefit/risk ...
Most Oncologic Drugs Advisory Committee members took issue with the lack of dosing optimization and the lack of US patient ...
GSK has failed to win the backing of influential advisers to the US drugs regulator for a key blood cancer drug, putting its ...
On a quest to bring its multiple myeloma antibody-drug conjugate Blenrep back to the U.S. | Members of the FDA's Oncologic ...
The panelists flagged safety concerns with Blenrep and GSK’s failure to optimize its dosing regimen for the antibody-drug ...
GSK (GSK) stock slips as FDA advisors vote against the approval of a combination regimen involving thecompany's blood cancer drug Blenrep. Read more here.
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.
Despite the setback with the Oncologic Drugs Advisory Committee vote, GSK emphasizes the unmet need in multiple myeloma and ...
The FDA oncologic drugs advisory committee voted against the approval of GSK’s blood cancer treatment Blenrep, delivering a setback to the drugmaker’s efforts to reintroduce the drug to the U.S.
The British pharmaceutical company said combinations for its Blenrep drug were evaluated in adults with relapsed or refractory multiple myeloma who have previously received at least one line of ...
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