Archive for November 2025

The U.S. Food and Drug Administration today approved Itvisma (onasemnogene abeparvovec-brve) for the treatment of spinal muscular atrophy (SMA) in adult and pediatric patients 2 years of age and older with confirmed mutation in the survival motor neuron 1 (SMN1) gene. Source: FDA Press Releases

The U.S. Food and Drug Administration today announced a pilot program designed to streamline communications with sponsors following formal meetings. Source: FDA Press Releases

The U.S. Food and Drug Administration today announced it is taking action to approve new labeling submitted by the company that includes the addition of a Boxed Warning, the agency’s most prominent safety warning, to Elevidys (delandistrogene moxeparvovec-rokl), and that the indication section of th Source: FDA Press Releases

The U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) today announced that Richard Pazdur, M.D., has been appointed director of the Center for Drug Evaluation and Research (CDER). Pazdur is a 26-year veteran of the FDA. Source: FDA Press Releases

The U.S. Department of Health and Human Services (HHS) today announced historic action to restore gold-standard science to women’s health. Source: FDA Press Releases

The U.S. Food and Drug Administration today announced six additional awardees under the Commissioner’s National Priority Voucher (CNPV) pilot program. Source: FDA Press Releases

The U.S. Food and Drug Administration issued 18 warning letters to owners of websites illegally marketing unapproved and misbranded botulinum toxin products, commonly called Botox. Source: FDA Press Releases