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

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

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

Pharmaceutical Technology serves as the connection to bio manufacturing and development, featuring regulatory updates and ...

Vaccination of pregnant women has been linked to a drop in newborns being admitted to hospital with a serious lung infection, ...

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 (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 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.

“Appropriate people at higher risk should be vaccinated, and this will not only benefit the vaccinated person, but will ...

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

Respiratory syncytial virus (RSV) infections were associated with significantly increased risk for complications beyond ...

"A regulatory decision by the FDA on this submission is expected in H1 2026. GSK is continuing to seek expanded indications for its RSV vaccine in other geographies including in the European Economic ...