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 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 ...

Phase 3 clinical trial data showed the GSK vaccine had an efficacy of 82.6% in preventing confirmed lower respiratory tract disease caused by RSV. The vaccine includes an adjuvant, a compound that ...

Preliminary data from GSK shows its RSV vaccine, Arexvy, could help protect people ages 50 to 59 against the virus. Leon Neal/Getty Images/FILE. CNN — ...

New: The FDA has expanded the approval for GSK’s vaccine to protect against respiratory syncytial virus, or RSV, authorizing its use for at-risk adults as young as 50.

The Wednesday approval of the GSK vaccine, known in development as RSVPreF3 OA, covers the prevention of RSV infection in adults age 60 and older. GSK will market its new product under the brand ...

The expanded recommendation is good news for Moderna, Pfizer, and GSK, which all sell RSV vaccines for older adults. Moderna shares were up 5.9% on Wednesday, while Pfizer was up 1%. GSK’s American ...

GSK is also asking for an order that permanently stops Pfizer from making or selling its RSV vaccine in the U.S. for adults over 60. The company stopped short of seeking to restrain Abrysvo’s ...

Pfizer , which dominated COVID vaccine sales, now finds itself looking up at GSK , whose rival new respiratory syncytial virus (RSV) vaccine has surged to an early lead since the shots launched ...