FDA accepts Merck's sBLA for Enflonsia to cover second RSV season
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U.S. FDA Accepts sBLA for ENFLONSIA™ (clesrovimab-cfor) to Update its Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease Indication to Include Children Under Two Years at Increased Ri
August 6, 2026 6:45 AM EDTEMA also accepts application for the same population for ENFLONSIA based on results from the Phase 3 SMART trial
If approved, children under two years of age at increased risk for severe RSV disease will be eligible to receive an additional dose of ENFLONSIA for their second RSV season
RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for... More
