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 ...

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 ...

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 ...

London: GSK plc has announced that the US Food and Drug Administration (FDA) has accepted for review an application to extend ...

GSK plc GSK announced that the FDA has accepted its regulatory filing seeking to expand the use of its RSV vaccine, Arexvy, in adults under 50 who are at a higher risk of the disease. A final decision ...

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

The UK's medicines regulator has warned NHS healthcare staff about an increased risk of a condition affecting the nerves in ...

RSV has outstripped severe Covid and flu hospitalisation rates and proved itself more fatal than either of the flu season ...

GSK plc GSK has announced the approval of the European Commission (EC) for the expanded use of its respiratory syncytial virus (RSV) vaccine, Arexvy, in adults aged 50-59 years. The vaccine has ...

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

The safety and immunogenicity of Arexvy in adults aged 18 to 49 years at increased risk of RSV disease (n=395) was compared with adults aged 60 and older (n=417) in a phase 3b open-label trial ...