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 ...

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

The syringe removes the need to reconstitute separate vials prior to administration, which simplifies the vaccine administration process for healthcare professionals, GSK said Thursday. The existing ...

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 ...

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

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 ...

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

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

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 ...