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.

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

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 ...

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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 ...

Arexvy is currently approved for use in all individuals aged 60 and older, as well as for high-risk individuals aged 50-59.

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 ...

Residents in public residential aged care services aged 60 and over can now claim a free vaccine for Respiratory Syncytial ...

Abrysvo is already approved for use in older adults agreed 60 and above, where it faces competition from GSK's Arexvy, and an FDA decision on maternal use is due in August.