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 ...

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

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

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 ...

Moderna stock has faced heavy pressure from negative headlines, regulatory setbacks and political uncertainty. See why I ...

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

Recent health news highlights various developments, including Trump's spending bill impacting insurance costs, a major acquisition in the bioscience sector, and GSK's efforts to expand RSV vaccine ...

FDA accepts GSK's filing to extend Arexvy's RSV vaccine use to high-risk adults under 50, with a decision due in 2026.

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

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

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 ...

GSK has applied to the US Food and Drug Administration (FDA) to extend use of its respiratory syncytial virus (RSV) vaccine Arexvy to adults under the age of 50 who are at increased risk of the ...