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

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

GSK (GSK) announced the US Food and Drug Administration, FDA, has accepted for review a Biologics License Application, BLA, for Blenrep in combinations with bortezomib plus dexamethasone and ...

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

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

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 ...

GSK PLC said on Monday that the US Food & Drug Administration accepted a biologics license application for its Blenrep combinations for the treatment of relapsed and refractory multiple myeloma, both ...

On Tuesday, GSK plc (NYSE:GSK) released the headline results of the GLISTEN global phase 3 trial evaluating linerixibat 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 ...

The key secondary end point of overall survival (OS) was met in the DREAMM-7 trial of belantamab mafodotin (Blenrep; GSK) for the treatment of patients with relapsed/refractory multiple myeloma (R/R ...

Also Read: GSK Raises Prospects For Withdrawn Blood Cancer Drug Blenrep To Return To US Market – Here’s Why The trial recruited PBC patients with moderate to severe itch who were receiving ...

GSK is increasingly confident that its anti-BCMA drug Blenrep could be returned to the US market, after revealing data from the DREAMM-8 trial of the drug in multiple myeloma at ASCO. Adding ...