GSK announces US FDA accepts application to review expanded use of RSV vaccine, Arexvy for adults 18-49 at increased risk: London, UK Wednesday, July 16, 2025, 14:00 Hrs [IST] GSK ...

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 ...

With GSK kicking its research and development engine into high gear in recent years, a shuffling of the scientific priorities ...

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

GSK has expanded its voluntary licensing agreement with the United Nations-backed Medicines Patent Pool (MPP) for cabotegravir, allowing it to be produced by three generic drugmakers and supplied to ...

Briefing documents were disclosed relating to the meeting of the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC), which will convene July 17 on the matter of London-based GSK plc’s Blenrep ...

FDA accepts GSK's application to expand Arexvy vaccine use to at-risk adults aged 18–49, with a decision expected in the ...

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

Proposals by Robert F. Kennedy Jr. and Bernie Sanders range from more disclosures in commercials to an outright ban.

In a recent regulatory development, the Subject Expert Committee (SEC) under the Oncology division of the Central Drugs ...

London: GSK plc has announced that the US Food and Drug Administration (FDA) has accepted for review an application to extend ...

FDA accepts GSK's filing to extend Arexvy's RSV vaccine use to high-risk adults under 50, with a decision due in 2026.