GSK has applied to the US Food and Drug Administration (FDA) to extend use of its respiratory syncytial virus (RSV) vaccine Arexvy to adults under the age of 50 who are at increased risk of 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 ...

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 ...

Arexvy is currently approved to prevent lower respiratory tract disease (LRTD) caused by RSV in individuals aged 60 years and older, and those 50 to 59 years of age who are at increased risk for LRTD ...

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"A regulatory decision by the FDA on this submission is expected in H1 2026. GSK is continuing to seek expanded indications for its RSV vaccine in other geographies including in the European Economic ...

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 ...

GSK Submits Arexvy for adults 18+ with EMA | Regulatory NewsGSK plc (LSE/NYSE: GSK) today announced that the European Medicines Agency has accepted for review the marketing authorisation ...