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.

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

(RTTNews) - GSK plc (GSK, GSK.L) announced that the FDA has accepted for review an application to extend the indication of Arexvy or respiratory syncytial virus vaccine, adjuvanted to adults aged ...

US FDA accepts application to review expanded use of GSK's RSV vaccine, Arexvy, for adults 18-49 at increased risk · More than 21 million US adults under the age of 50 have at least one risk ...

In the US, one study suggested Abrysvo and Arexvy were associated with nine and seven excess Guillain-Barre syndrome cases per million vaccine doses administered, respectively.

GSK's Arexvy and Pfizer's Abrysvo are approved for the prevention of lower respiratory tract disease caused by RSV in adults aged 50 to 59 and 18 to 59, respectively, who are at an increased risk ...

What Are the Key Trends Shaping the Abrysvo or Arexvy Market? A significant industry trend is the expansion of vaccine indications to include broader age groups.

Abrysvo and Arexvy will now be required to come with labeling that includes a warning about a potential increased risk of Guillain-Barré Syndrome.