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 ...

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 ...

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 ...

Welcome to Fierce Pharma's regulatory tracker for the second half of 2025. | In this tracker, Fierce Pharma is recording the ...

The Food and Drug Administration on Wednesday approved Arexvy, the world's first respiratory syncytial virus (RSV) vaccine — a scientific breakthrough 60 years in the making.

The US FDA approved an RSV vaccine called Arexvy. How effective is it, when will it be available, and who can take it? CNN Medical Analyst Dr. Leana Wen explains.

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 ...

Health Canada has approved an RSV vaccine for adults over the age of 60 — something many doctors were "happy" to learn. The agency approved GSK’s Arexvy vaccine for the prevention of RSV ...