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 ...

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

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

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 ...

Arexvy is currently approved for use in all individuals aged 60 and older, as well as for high-risk individuals aged 50-59.

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 ...

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

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 ...

The offering, the first IPO this year, attracted more than 32 billion dirhams ($3.5 bln) in demand for 500 million dirhams in shares. GSK seeks FDA nod for expanded use of RSV vaccine in adults ...

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

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