Merck says FDA accepts sBLA to expand ENFLONSIA RSV prevention to high-risk children under 2 for second season

PUBT · 1d ago
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.


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