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’s 3 billion pounds sterling peak sales goal for its multiple myeloma drug Blenrep appears increasingly attainable thanks ...

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

GSK is carving out a niche for Blenrep in the second-line multiple myeloma setting, for which it projects multi-blockbuster ...

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 ...

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 ...

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

GSK reported positive results from its phase three ‘DREAMM-7’ trial on Thursday, highlighting a significant overall survival ...

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