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 ...
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 ...
Also Read: GSK’s Q3 Earnings Hit By Lower Than Expected Vaccine Sales, Cautions Lower Revenue For 2024 A phase 3 study in ...
GSK's drive to resurrect its multiple myeloma therapy Blenrep has continued with new data from the DREAMM-7 trial showing an increase in overall survival (OS) with the drug had reached statistical ...
GSK plc (GSK, GSK.L) announced that the US Food and Drug Administration has accepted for review a Biologics License Application (BLA) ...
GSK reported positive results from its phase three ‘DREAMM-7’ trial on Thursday, highlighting a significant overall survival ...
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 ...
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Blenrep was withdrawn from the U.S. market after the failure of GSK’s phase III confirmatory study, DREAMM-3, which evaluated Blenrep in patients with relapsed or refractory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.