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GlobalData on MSNGSK eyes FDA label expansion for RSV vaccine Arexvy to include younger patientsGSK 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 ...
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 ...
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Zacks.com on MSNFDA Accepts GSK Filing for Expanded Use of RSV Shot in Younger AdultsFDA accepts GSK's filing to extend Arexvy's RSV vaccine use to high-risk adults under 50, with a decision due in 2026.
British drugmaker GSK said on Monday it had submitted an application to the U.S. Food and Drug Administration to extend the ...
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 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 ...
"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 ...
Pharmaceutical Technology serves as the connection to bio manufacturing and development, featuring regulatory updates and ...
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 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 ...
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 ...
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