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 ...

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

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.

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

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 ...

OPEN The FTSE 100 was expected to open 9.7 points lower ahead of the bell on Monday after wrapping up the previous session 0.38% softer at 8,941.12.

"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 ...

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

GSK Submits Arexvy for adults 18+ with EMA | Regulatory NewsGSK plc (LSE/NYSE: GSK) today announced that the European Medicines Agency has accepted for review the marketing authorisation ...

Guillain-Barre syndrome is a rare but serious condition which needs urgent treatment in hospital to prevent it progressing.

GSK said in a statement that it is confident that it will be able to launch Arexvy in time for the 2023/24 RSV season, describing the new vaccine as a “turning point” in efforts to reduce the ...