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Merck says FDA accepts sBLA to expand ENFLONSIA RSV prevention to high-risk children under 2 for second season
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Merck says FDA accepts sBLA to expand ENFLONSIA RSV prevention to high-risk children under 2 for second season
  • FDA accepted Merck’s supplemental BLA for ENFLONSIA to extend RSV prevention to high-risk children under 2 in a second season.
  • PDUFA target action date set for March 22, 2027.
  • EMA also accepted a parallel application for the same population, supported by Phase 3 SMART trial data.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Merck & Co. Inc. published the original content used to generate this news brief on August 06, 2026, and is solely responsible for the information contained therein.

Disclaimer:This article represents the opinion of the author only. It does not represent the opinion of Webull, nor should it be viewed as an indication that Webull either agrees with or confirms the truthfulness or accuracy of the information. It should not be considered as investment advice from Webull or anyone else, nor should it be used as the basis of any investment decision.
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