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

FDA reviewers said in briefing documents that the benefit-risk profile of the drug for the treatment of multiple myeloma “remains unclear.” ...

GSK has been enjoying regulatory momentum in recent months as it works to bring its antibody-drug conjugate (ADC) Blenrep back to markets around the globe. | As GSK's Blenrep makes its return to ...

GSK (GSK) stock in focus as the FDA staff raise safety concerns over Blenrep combo for multiple myeloma ahead of an AdCom ...

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

The offering, the first IPO this year, attracted more than 32 billion dirhams ($3.5 bln) in demand for 500 million dirhams in shares. GSK seeks FDA nod for expanded use of RSV vaccine in adults ...

A quiet shift with potentially big implications for cancer drug access is underway in the UK. In June, the country’s health ...

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However, in November 2022, Blenrep was withdrawn from the U.S. market after the failure of GSK’s phase III confirmatory study, DREAMM-3, which evaluated Blenrep in patients with relapsed or ...

GSK wins CHMP nod for Blenrep combos in relapsed or refractory multiple myeloma. A decision in the EU is expected in the third quarter of 2025.