Also known as Synagis.
FDA accepted an sBLA to add children under two at increased risk for severe RSV for a second-season dose; PDUFA Mar 22, 2027; EMA accepted a parallel filing.
ENFLONSIA shows consistent safety and efficacy in high-risk infants over two RSV seasons, supporting expanded use for children under 2.
ENFLONSIA™ awaits EU approval for infant RSV prevention, offering a single-dose option for all weights. Backed by Phase 2b/3 and Phase 3 trials, decision expected by year-end.
