The U.S. Food and Drug Administration has reopened a safety review of two approved monoclonal antibodies used to prevent respiratory syncytial virus (RSV) in infants. The agency informed drugmakers last week and is reexamining post‑marketing safety data for products already on the market. The move follows growing regulatory attention to pediatric preventive products and signals heightened post‑approval surveillance by the FDA. Drug sponsors should expect additional data requests and potential labeling or usage guidance changes as the agency completes its reassessment. Clinical programs and commercial planning for pediatric RSV prevention may need to adjust timelines and risk communications while the agency evaluates any new safety signals.