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