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…

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…

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…

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

The U.S. Food and Drug Administration today announced actions to restrict the sale of unapproved ingestible fluoride prescription drug products for children. Source: FDA Press Releases

The U.S. Food and Drug Administration (FDA) today announced significant action to make it faster and less costly to develop biosimilar medicines, which are lower-cost “generic” alternatives to biologic drugs…

FDA issued an Emergency Use Authorization (EUA) concluding that based on the scientific evidence available, Credelio (lotilaner) chewable tablets may be effective in treating New World screwworm (NWS) infestations in…