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.
London: GSK plc has announced the US Food and Drug Administration (FDA) has accepted for review a Biologics License ...
GSK plc (GSK, GSK.L) announced that the US Food and Drug Administration has accepted for review a Biologics License Application (BLA) ...
Findings from a phase 3 trial with Blenrep, Velcade and dexamethasone in relapsed/refractory multiple myeloma will be ...
GlaxoSmithKline (GB:GSK) has released an update.Don't Miss our Black Friday Offers:Unlock your investing potential with TipRanks Premium - Now ...
Blenrep was withdrawn from the U.S. market after the failure of GSK’s phase III confirmatory study, DREAMM-3, which evaluated Blenrep in patients with relapsed or refractory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.
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 ...
The US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for belantamab ...