Palivizumab news

All news on Palivizumab (also known as Synagis): plants, production capacities, investments and involved companies.

6 August 2026

Merck seeks FDA sBLA to extend ENFLONSIA protection for high‑risk under‑2s through second RSV season

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.
19 February 2026

Merck Reports Positive Phase 3 Trial Results for ENFLONSIA in High-Risk Infants and Children

ENFLONSIA shows consistent safety and efficacy in high-risk infants over two RSV seasons, supporting expanded use for children under 2.
19 September 2025

Merck's ENFLONSIA™ Recommended by EU CHMP for RSV Prevention in Infants

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.

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