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 ...

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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 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.

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

AS01-adjuvanted RSV and shingles vaccines were tied to a lower dementia risk in older adults. Compared with flu vaccine recipients, those who had the AS01 RSV shot had 29% more dementia-free time ...

Moderna stock has faced heavy pressure from negative headlines, regulatory setbacks and political uncertainty. See why I ...

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 ...

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 ...

The U.S. Food and Drug Administration approved a pre-filled syringe version of GSK's blockbuster shingles vaccine Shingrix, ...

The syringe removes the need to reconstitute separate vials prior to administration, which simplifies the vaccine administration process for healthcare professionals, GSK said Thursday. The existing ...