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 18-49 who are at increased risk. GSK's RSV vaccine is approved in the US for the prevention of lower respiratory tract disease caused by RSV in adults aged 60 and older, and for those aged 50-59 years who are at increased risk. A regulatory decision by the FDA on the submission is expected in first half, 2026.
GSK said it is continuing to seek expanded indications for RSV vaccine in other geographies including in the European Economic Area and Japan.
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Business News
May 08, 2026 15:50 ET Manufacturing and services sector survey results and labor market data from main economies were the highlight on the economics news front this week. Factory orders and jobs report dominated the news flow in the U.S. Similarly, industrial production data from German garnered attention in Europe. In Asia, purchasing managers’ survey results from China and the central bank decision from Australia were in focus.