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

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 ...

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

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 ...

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 ...

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.

GSK’s vaccines rouse the body’s immunity with an RSV surface protein called the F glycoprotein. Before the virus breaks in and enters the host cell, it exists in a lollipop-shaped prefusion form .

GSK said that its vaccine against RSV reduced the risk of developing lower respiratory tract disease by 82.6% in a large trial. Photo: kenzo tribouillard/Agence France-Presse/Getty Images ...

GSK does not expect initial uptake of its RSV vaccine will be as swift as it was for its blockbuster shingles vaccine, though the company is confident in its new inoculation, Chief Executive Emma ...

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 ...