GSK plc GSK announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion recommending approval for the Blenrep ...

Blenrep, an antibody-drug conjugate (ADC), is under review in global markets, including the US, with a prescription drug user fee act (PDUFA) date set for 23 July 2025.

BLENREP is a first-in-class anti-BCMA (B-cell maturation antigen) therapy for patients whose disease has progressed despite prior treatment with an immunomodulatory agent, proteasome inhibitor and ...

GSK confirmed this morning that the disappointing readout from the DREAMM-3 trial of multiple myeloma therapy Blenrep reported earlier this month means that it will take the drug off the US market.

The FDA has approved GlaxoSmithKline’s multiple myeloma drug Blenrep, a first-in-class potential blockbuster that will be used in advanced disease.

The Blenrep comeback continues for GSK. The blood cancer treatment, which was once pulled off the market, was found to help patients live longer in a Phase 3 clinical trial, the results of which were ...

GSK has secured the first regulatory approval for Blenrep since the antibody-drug conjugate’s global market withdrawal in 2022. The U.K.’s Medicines and Healthcare products Regulatory Agency ...

GSK’sGSK-2.26 % decrease; red down pointing triangle blood-cancer drug Blenrep showed positive overall survival data in a late-stage trial, increasing the likelihood for the treatment to return ...

The Blenrep results presented Monday are from a Phase 3 test, DREAMM-7, that enrolled nearly 500 patients whose multiple myeloma relapsed or was refractory to at least one earlier line of therapy.

GSK’s blood cancer drug Blenrep won regulatory approval in the U.K. on Thursday, marking the medicine’s return to the market after it was withdrawn several years ago.

GSK's Blenrep approved in the U.K. for multiple myeloma after strong phase 3 data showing improved survival in DREAMM-7 and DREAMM-8 trials.