The US Food and Drug Administration (FDA) is expected to make a Prescription Drug User Fee Act (PDUFA) decision by mid-2025.

GSK plc GSK announced that the FDA accepted its biologics license application (BLA) seeking approval for the Blenrep ...

GSK continues to build the case for its multiple myeloma therapy Blenrep, which was pulled from the US market last year, with another positive phase 3 trial. The BCMA-targeted antibody-drug ...

GSK plc (GSK, GSK.L) announced that the US Food and Drug Administration has accepted for review a Biologics License Application (BLA) ...

Pharma titan GSK has announced that US regulators have accepted for review Blenrep combinations for the treatment of relapsed ...

GSK (GSK) announced the US Food and Drug Administration ... plus dexamethasone and pomalidomide plus dexamethasone for the treatment of patients with multiple myeloma who have received at least one ...

Findings from a phase 3 trial with Blenrep, Velcade and dexamethasone in relapsed/refractory multiple myeloma will be ...

London: GSK plc has announced the US Food and Drug Administration (FDA) has accepted for review a Biologics License ...

After its market withdrawal in 2022, GSK’s multiple myeloma drug Blenrep (belantamab mafodotin) is poised to re-enter the treatment landscape for multiple myeloma. The US Food and Drug ...

Blenrep was withdrawn from the U.S. market after the failure of GSK’s phase III confirmatory study, DREAMM-3, which evaluated Blenrep in patients with relapsed or refractory multiple myeloma.