FDA accepts GSK's application to expand Arexvy vaccine use to at-risk adults aged 18–49, with a decision expected in the ...

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 ...

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

As FDA kicked off the drug user fee reauthorization process, Commissioner Marty Makary said he’d like to see lower fees paid ...

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 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 ...

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

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

The new RSV recommendation calls for a single dose of vaccine for adults age 50 to 59 years who are at increased risk of ...

GSK specialty medicines grew YoY in Q1 2025, and it is now the main profit engine, offsetting the weakness in their vaccine ...