The FDA has accepted for review the sBLA to expand the indication of Arexvy (RSV vaccine, adjuvanted) to adults aged 18 to 49 years who are at increased risk.

The label expansion sought by GSK is a bid to compete with Pfizer and Moderna in the younger age groups of the RSV vaccine market. Pfizer’s Abrysvo and Moderna’s mRESVIA are both approved to prevent ...

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.

British drugmaker GSK said on Monday it had submitted an application to the U.S. Food and Drug Administration to extend the ...

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 ...

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 ...

Pharmaceutical Technology serves as the connection to bio manufacturing and development, featuring regulatory updates and ...

The usually sluggish FTSE 100 is having a surprisingly good year. But our writer feels there are still potential bargains ...

Recent health news highlights various developments, including Trump's spending bill impacting insurance costs, a major acquisition in the bioscience sector, and GSK's efforts to expand RSV vaccine ...

RSV has outstripped severe Covid and flu hospitalisation rates and proved itself more fatal than either of the flu season ...

Not content with taking on the respiratory syncytial virus (RSV) prevention market with its antibody-based therapy Beyfortus, AstraZeneca has agreed to buy US biotech Icosavax and its phase 3 ...