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

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

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

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 ...

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

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 ...

"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 ...

As FDA kicked off the drug user fee reauthorization process, Commissioner Marty Makary said he’d like to see lower fees paid ...

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 ...

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 ...

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 ...

GSK said the US Food and Drug Administration has accepted an application for review to extend the indication of its Arexvy respiratory syncytial virus vaccine to adults aged 18-49 who are at increased ...