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.

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

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 announced that the FDA has accepted its regulatory filing seeking to expand the use of its RSV vaccine, Arexvy, in adults under 50 who are at a higher risk of the disease. A final decision ...

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 ...

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 ...

GSK's major growth drivers, Shingrix and Arexvy, along with recent legal progress, make its current undervaluation unjustified. See what to expect from GSK's Q3.

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 ...

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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.

GSK gets EU approval for its RSV vaccine Arexvy in a younger age group, a potential leg-up in a market tussle with Pfizer and Moderna ...

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 ...