FDA accepts application to expand Merck's RSV antibody ENFLONSIA into new season
The US Food and Drug Administration (FDA) has accepted Merck & Co's (NYSE: MRK) supplemental Biologics License Application (sBLA) for its respiratory syncytial virus (RSV) antibody Enflonsia (clesrovimab-cfor), seeking to expand its indication to children under two years old at increased risk of severe RSV disease through their second RSV season.
According to Merck, the FDA has set a target action date of March 22, 2027. The European Medicines Agency accepted a matching application for the European Union (EU) in July 2026.
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