FDA approved Papzimeos, the first-of-its-kind non-replicating adenoviral vector-based immunotherapy for use in adults with recurrent respiratory papillomatosis. Source: FDA Press Releases

Statement from FDA Commissioner Marty Makary, M.D., M.P.H., on Florida Restriction of 7-OH Opioid Products Source: FDA Press Releases

U.S. FDA Commissioner Dr. Marty Makary, M.D., M.P.H., and U.S. Secretary of Agriculture Brooke L. Rollins this week announced plans to support American citrus growers and cut bureaucratic barriers by…

A Statement from FDA Commissioner Marty Makary, M.D., M.P.H: Announcing Resolution of the IV Saline Solutions Shortage Source: FDA Press Releases

The U.S. Food and Drug Administration today announced FDA PreCheck, a new program to strengthen the domestic pharmaceutical supply chain by increasing regulatory predictability and facilitating the construction of manufacturing…

The U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) today announced that Sean Keveney has been appointed Chief Counsel at the FDA. Source:…

FDA Requires Major Changes to Opioid Pain Medication Labeling to Emphasize Risks Source: FDA Press Releases

FDA Takes Steps to Restrict 7-OH Opioid Products Threatening American Consumers Source: FDA Press Releases

FDA Recommends Removal of Voluntary Hold for Elevidys for Ambulatory Patients Source: FDA Press Releases

The U.S. Food and Drug Administration is investigating the death of an 8-year-old boy who received Elevidys, a Sarepta Therapeutics gene therapy for Duchenne muscular dystrophy. Source: FDA Press Releases