New Human Medicines: RSS Feed from EMA
- Human medicines European public assessment report (EPAR): Winlevi, clascoterone, Status: Opinion
- Human medicines European public assessment report (EPAR): Syfovre, pegcetacoplan, Status: Application withdrawn
- Human medicines European public assessment report (EPAR): Dazublys, trastuzumab, Date of authorisation: 30/06/2025, Status: Authorised
- Human medicines European public assessment report (EPAR): Nurzigma, pridopidine, Status: Opinion under re-examination
- Human medicines European public assessment report (EPAR): Jelrix, autologous cartilage-derived articular chondrocytes, in-vitro expanded, Status: Opinion under re-examination
MedWatch Safety Alert RSS Feed
- Ventilator Correction: Hamilton Medical AG Corrects HAMILTON-C6 Due to Risk of Ventilation Interruption from Defective Circuit Board
- Infusion Pump Correction: ICU Medical, Inc. Issues Correction for Plum Duo Infusion System Due to Software Possibly Resulting in Pump Becoming Unresponsive
- Applicator Recall: Integra LifeSciences Removes Extended Tip Applicator Due to Potential Sterility and Endotoxin Concerns
- Unichem Pharmaceuticals (USA) Inc. Issues Voluntary Nationwide Recall of Cyclobenzaprine Hydrochloride Tablets USP 10 mg, Due to Mislabeling
- FDA Update on the Safety of Ixchiq (Chikungunya Vaccine, Live). FDA Suspends Biologics License: FDA Safety Communication
- Follow Instructions for Safe Use of Hyperbaric Oxygen Therapy Devices - Letter to Health Care Providers
- Vascular Stent Recall: Boston Scientific Removes Carotid WALLSTENT Monorail Endoprosthesis Due to Risk of Resistance During Device Withdrawal
- B. Braun Medical Issues Voluntary Nationwide Recall of Lactated Ringer’s Injection USP 1000 mL and 0.9% Sodium Chloride Injection USP 1000 mL Due to the Presence of Particulate Matter
- Early Alert: Infusion Pump Issue from Baxter
- Early Alert: Cardiac Cannula Issue from Medtronic
FDA Stay Informed on New Drugs
- Pharmacy Compounding Advisory Committee Roster
- Antimicrobial Drugs Advisory Committee (formerly known as the Anti-Infective Drugs Advisory Committee) Roster
- Generic Drug Facilities, Sites and Organization Lists
- Drug Safety Communications
- FDA to recommend additional, earlier MRI monitoring for patients with Alzheimer’s disease taking Leqembi (lecanemab)
- Table of Surrogate Endpoints That Were the Basis of Drug Approval or Licensure
- Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) Program
- Buying & Using Medicine Safely
- BeSafeRx: Your Source for Online Pharmacy Information
- Drugs@FDA Data Files