US FDA accepts application to review expanded use of GSK’s RSV vaccine, Arexvy, for adults 18-49 at increased risk

GSK

14 July 2025 - FDA decision anticipated H1, 2026

GSK today announced that the US FDA has accepted for review an application to extend the indication of Arexvy (respiratory syncytial virus (RSV) vaccine, adjuvanted) to adults aged 18-49 who are at increased risk.

Read GSK press release

Michael Wonder

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Michael Wonder

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US , Vaccine , Dossier , Registration