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 ...

GSK plc (GSK) said on Monday that its application for extending the use of its respiratory syncytial virus (RSV) vaccine Arexvy to adults aged 18-49 who are at increased risk of contracting the ...

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

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 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 ...

GSK expects to launch its respiratory syncytial virus (RSV) vaccine in the U.S. this year without supply constraints and sees China as a major future market for the shot, ...

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 — ...