The FDA approved Merck’s RSV antibody injection Enfanzia for newborns and infants, positioning the company to capture a projected $13.59 billion global RSV market by 2030. However, clinical trials revealed higher serious adverse events (SAEs) in the Enfanzia group compared to placebo, including neurological issues, deaths, and increased infection rates. The approval faces uncertainty as the CDC’s ACIP committee may be influenced by recent changes to its leadership.

The U.S. Food and Drug Administration approved Merck's RSV antibody, Enflonsia, for infants up to one year old to protect against respiratory syncytial virus (RSV). The drug, the first preventive shot for infants, is priced at $556 per dose and has a comparable safety profile to Synagis. Merck expects shipments for the 2025-2026 RSV season, while Sanofi and AstraZeneca's Beyfortus faces supply challenges despite increased production.

The U.S. Food and Drug Administration approved Merck's RSV antibody shot, Enflonsia, for infants up to one year old to protect against respiratory syncytial virus (RSV). The drug, clesrovimab, is the first preventive shot for infants regardless of birth weight and is priced at $556 per dose. It was compared to Synagis, a monthly injection, and Merck expects shipments for the 2025-2026 RSV season. The approval follows supply challenges with Beyfortus and CDC recommendations for RSV prevention.

The FDA approved Merck's RSV vaccine, Enflonsia, for infants, offering a new treatment option to compete with Sanofi and AstraZeneca's Beyfortus. The approval allows Merck to launch the drug ahead of the RSV season, with trial data showing significant reductions in hospitalizations for infants.

The U.S. Food and Drug Administration approved Merck's monoclonal antibody, Enflonsia, as a single-dose preventive treatment for infants up to one year old against respiratory syncytial virus (RSV). The drug, priced at $556 per dose, is the first of its kind to be effective regardless of birth weight. The approval follows clinical trials showing comparable safety to Synagis, with Merck expecting shipments for the 2025-2026 RSV season. The FDA's decision comes amid ongoing discussions about RSV prevention strategies and supply chain challenges.