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GSK's RSV vaccine for adults 50-59 at increased risk accepted by FDA for Priority Review

GSK plc's application to extend its RSV vaccine indication to adults aged 50-59 at risk has been accepted by the FDA for priority review. If approved, it would be the first vaccine for this population. The application is supported by positive phase III trial results. ....

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GSK's RSV Vaccine, AREXVY, Accepted Under Priority Review in US for the Prevention of RSV Disease in Adults Aged 50-59 at Increased Risk -February 06, 2024 at 07:04 am EST

Application supported by positive results of a phase III trial showing immune response and acceptable tolerability profile in this population

Adults aged 50 and above with underlying medical. ....

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GSK : Japan's Ministry of Health, Labour and Welfare accepts Arexvy regulatory application to prevent RSV disease in adults aged 50-59 at increased risk - Form 6-K -December 12, 2023 at 06:09 am EST

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Form 6-K

REPORT OF FOREIGN PRIVATE ISSUER. ....

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GSK's RSV vaccine Arexvy accepted for review by Japan's MHLW

GSK's RSV vaccine Arexvy accepted for review by Japan's MHLW
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