Zacks.com on MSN4d
FDA Accepts GSK's BLA for Blenrep Combos in Multiple Myeloma
GSK plc GSK announced that the FDA accepted its biologics license application (BLA) seeking approval for the Blenrep ...
Benzinga.com16d
GSK Raises Prospects For Withdrawn Blood Cancer Drug Blenrep To Return To US Market - Here's Why
The DREAMM-7 trial showed Blenrep with BorDex lowered death risk in relapsed/refractory multiple myeloma vs. standard ...
Cure Today12d
Blenrep-Based Combo Provides Survival Benefit in Relapsed/Refractory Multiple Myeloma
Findings from a phase 3 trial with Blenrep, Velcade and dexamethasone in relapsed/refractory multiple myeloma will be ...
The Pharma Letter15d
Blenrep results ‘transformative’, GSK says
UK drugmaker GSK might be trading lower following Thursday’s nomination of vaccine sceptic Robert F Kennedy Jr as the USA’s ...
GlobalData on MSN15d
GSK reports positive outcomes from Phase III multiple myeloma treatment trial
GSK has announced positive headline interim analysis outcomes from a Phase III trial, which is evaluating Blenrep (belantamab ...
GSK :FDA Accepts Blenrep Combination For Review In Treatment Of Relapsed/Refractory Multiple Myeloma
GSK plc (GSK, GSK.L) announced that the US Food and Drug Administration has accepted for review a Biologics License Application (BLA) ...
GlobalData on MSN5d
GSK eyes up combo approval for previously withdrawn myeloma drug
The US Food and Drug Administration (FDA) is expected to make a Prescription Drug User Fee Act (PDUFA) decision by mid-2025.
GSK's Blenrep treatment accepted for review by FDA
Pharma titan GSK has announced that US regulators have accepted for review Blenrep combinations for the treatment of relapsed ...
Business Insider5d
GSK announces FDA accepeted for review a BLA for Blenrep
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 ...
London South East5d
Blenrep combinations accepted for US FDA review
Regulatory submission supported by phase III head-to-head DREAMM-7 and DREAMM-8 trials showing statistically significant efficacy, including overall survival in DREAMM-7 · If approved ...
Nasdaq4d
FDA Accepts GSK's BLA for Blenrep Combos in Multiple Myeloma
GSK plc GSK announced that the FDA accepted its biologics license application (BLA) seeking approval for the Blenrep (belantamab mafodotin) combination therapy to treat relapsed or refractory ...