The U.S. House Appropriations Committee advances in a 35 to 27 vote FDAs fiscal year 2026 spending bill.
FDA posts a safety alert on Medtronic subsidiary Given Imaging and certain Bravo CF Capsule delivery devices, which are designed to monitor pH in a pa...
FDA issues a safety communication about two reports of fatal acute liver failure following treatment of Duchenne Muscular Dystrophy patients with Sare...
FDA warns Turkeys Pushclean Technology about CGMP violations in its manufacturing of over-the-counter drug products.
FDA warns South Koreas Aju Pharm about QS and MDR violations in its production of two Class 2 medical devices.
FDA says there will be no advisory committee review of Capricor Therapeutics BLA for Deramiocel, the companys lead cell therapy candidate for treating...
FDA posts an International Council for Harmonization draft guideline entitled Stability Testing of Drug Substances and Drug Products Q1.
A new study disputes previous assumptions about FDA inspections leading to more drug shortages at facilities receiving GMP citations.
