The FDA has accepted for review the sBLA to expand the indication of Arexvy (RSV vaccine, adjuvanted) to adults aged 18 to 49 years who are at increased risk.

(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 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 ...

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 ...

GSK plc today announced that AREXVY is now available in the US at all major retail pharmacies. In June, the Advisory Committee on Immunization Practices recommended that persons 60 years of age ...

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.

GSK's major growth drivers, Shingrix and Arexvy, along with recent legal progress, make its current undervaluation unjustified. See what to expect from GSK's Q3.

GSK shares positive data for AREXVY, its respiratory syncytial virus (RSV) older adult vaccine, indicating protection over two RSV seasons .

GSK Pfizer Arexvy RSV. As companies have flocked to compete in the new respiratory syncytial virus (RSV) vaccine market, GSK has had the best timing.

GSK's Q3 2023 financials reveal strong performance fueled by Arexvy's sales, while caution is advised due to market movements. Read more here.