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 ...

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

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.

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 ...

“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 ...

"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 ...

The UK drug watchdog has issued an alert to the NHS after the RSV jab was linked to a rare condition that needs "urgent ...

OVER 20 people developed a potentially paralysing illness after getting the respiratory syncytial virus (RSV) vaccine. The UK ...