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

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 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 ...

The label expansion sought by GSK is a bid to compete with Pfizer and Moderna in the younger age groups of the RSV vaccine market. Pfizer’s Abrysvo and Moderna’s mRESVIA are both approved to prevent ...

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 — ...

The Food and Drug Administration has approved three vaccines for RSV — GSK's GSK.L Arexvy, Moderna's MRNA.O mRESVIA and ...

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 ...