FDA Analyzing Safety of RSV Antibodies Approved for Young Children

The Food and Drug Administration is reviewing the safety of antibodies against respiratory syncytial virus (RSV) that have been cleared for use in babies and toddlers.
The probe is being conducted by the FDA’s Center for Drug Evaluation and Research (CDER), according to the government.
“FDA routinely evaluates emerging safety information and will update product labeling if warranted by the totality of the evidence,” a spokesperson for the Department of Health and Human Services, the FDA’s parent agency, told news outlets in a statement on Dec. 9.
“CDER’s team is rigorously reviewing the available data, as it does for all products, to ensure decisions remain rooted in evidence-based science.”…