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FDA Approvals

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FDA Approves Merck’s Enflonsia Monoclonal Antibody for Infant RSV Prevention

Merck plans July shipments of the single-dose antibody ahead of the 2025 RSV season with a CDC advisory review scheduled for late June.

FDA Approves First Treatment for Niemann-Pick Disease Type C

Study Finds CAR-T Therapy Does Not Increase Risk of Secondary Cancer

FDA Approves Neffy, the First Needle-Free Epinephrine Nasal Spray for Anaphylaxis