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

The FDA accepts GSK's BLA seeking approval of Blenrep combinations for treating relapsed/refractory multiple myeloma. A decision is due on July 23, 2025.

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

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

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

GlaxoSmithKline (GB:GSK) has released an update.Don't Miss our Black Friday Offers:Unlock your investing potential with TipRanks Premium - Now ...

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 ...

US FDA accepts for review GSK’s Blenrep combinations for the treatment of relapsed/refractory multiple myeloma: London, UK Tuesday, November 26, 2024, 09:00 Hrs [IST] GSK plc an ...

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

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

Also Read: GSK’s Q3 Earnings Hit By Lower Than Expected Vaccine Sales, Cautions Lower Revenue For 2024 A phase 3 study in ...

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