GSK has been enjoying regulatory momentum in recent months as it works to bring its antibody-drug conjugate (ADC) Blenrep ...

The U.S. Food and Drug Administration's staff reviewers on Tuesday raised safety concerns that GSK's blood cancer drug ...

The U.S. Food and Drug Administration's staff reviewers on Tuesday raised safety concerns that GSK's blood cancer drug ...

PDUFA date nears for GSK plc’s Blenrep (belantamab mafodotin), the U.S. FDA’s Oncologic Drugs Advisory Committee will decide July 17 on whether available data justify the return to market of the ...

Recent developments illustrate dynamic shifts in the healthcare sector. Trump's spending bill is anticipated to challenge ...

GSK specialty medicines grew YoY in Q1 2025, and it is now the main profit engine, offsetting the weakness in their vaccine ...

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 ...

However, in November 2022, Blenrep was withdrawn from the U.S. market after the failure of GSK’s phase III confirmatory study, DREAMM-3, which evaluated Blenrep in patients with relapsed or ...

In 2022, GSK withdrew the U.S. marketing authorization for Blenrep following the FDA request, based on the previously announced outcome of the DREAMM-3 Phase 3 confirmatory trial, which did not ...

GSK plc GSK announced that the European Medicines Agency (EMA) has accepted its marketing authorization application (MAA) seeking approval for the Blenrep (belantamab mafodotin) combination ...