RSS Feed from EMA on New Human Medicines
- Human medicines European public assessment report (EPAR): Xervyteg, Allogeneic faecal microbiota, pooled, Status: Opinion
- Human medicines European public assessment report (EPAR): Yartemlea, Narsoplimab, Status: Opinion under re-examination
- Human medicines European public assessment report (EPAR): Tacquell, Autologous melanoma-derived tumor infiltrating lymphocytes, ex vivo-expanded, Status: Opinion
- Human medicines European public assessment report (EPAR): Onswik, Insulin efsitora alfa, Status: Opinion
- Human medicines European public assessment report (EPAR): Nylaspeg, pegfilgrastim, Status: Opinion
- Human medicines European public assessment report (EPAR): Hopledo, levodopa,carbidopa, Status: Opinion
- Human medicines European public assessment report (EPAR): Denosumab Ascend, denosumab, Status: Opinion
- Human medicines European public assessment report (EPAR): Aujemflu, Influenza vaccine (surface antigen, inactivated, adjuvanted, prepared in cell culture), Status: Opinion
- Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 14-16 July 2026
- EMA and EISMEA boost cooperation to accelerate health innovations
- Executive Director Emer Cooke's speech at the European Parliament's Committee on Public Health
- Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 July 2026
- EMA fast tracks review of a medicine for metastatic pancreatic cancer
MedWatch Safety Alert RSS Feed
- Catheter Introducer Kit Recall: Abiomed Removes 14Fr Low Profile Introducer Kits
- Thoracic Stent Graft Recall: Bolton Medical Removes Relay Pro System
- Convenience Kit Recall: B. Braun Medical, Inc. Removes Spinal Anesthesia Kits Containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP
- Convenience Kit Correction: Arrow International Issues Correction for Convenience Kits Containing Recalled Huons Lidocaine and Bupivacaine and Saline
- Early Alert: Ventilator Issue from Resmed
- Positive Pressure Breathing Device Correction: Baxter Issues Correction for Volera Positive Pressure Breathing Devices
- Pulmonary Valve Catheter Delivery System Recall: Medtronic Removes Harmony Delivery Catheter System (DCS)
- Early Alert: Convenience Kit Issue from Medical Action Industries
- Early Alert: Convenience Kits Issue from Medline
- Infusion Pump Correction: Fresenius Kabi Issues Correction for Ivenix Large Volume Infusion Pump
FDA Stay Informed on New Drugs
- Internet Pharmacy Warning Letters
- Commissioner's National Priority Voucher (CNPV) Pilot Program
- Innovative Science and Technology Approaches for New Drugs (ISTAND) Program Submission Process
- FDA Approves First Oral PCSK9 Inhibitor to Lower LDL Cholesterol in Adults with High Cholesterol
- Novel Drug Approvals for 2026
- Drugs@FDA Data Files
- Human Drug Imports
- What's New Related to Drugs
- Drug Trials Snapshots
- eCTD Submission Standards for eCTD v3.2.2 and Regional M1