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 Risk for Severe RSV for Their Second Season
EMA 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:...