New Human Medicines: RSS Feed from EMA
- Human medicines European public assessment report (EPAR): Aplidin, plitidepsin, Status: Application withdrawn
- Human medicines European public assessment report (EPAR): Vivlipeg, pegfilgrastim, Date of authorisation: 18/08/2025, Status: Authorised
- Human medicines European public assessment report (EPAR): Enflonsia, clesrovimab, Status: Opinion
- Human medicines European public assessment report (EPAR): Imaavy, nipocalimab, Status: Opinion
- Human medicines European public assessment report (EPAR): Denosumab Intas, denosumab, Status: Opinion
- Human medicines European public assessment report (EPAR): Gobivaz, golimumab, Status: Opinion
- Human medicines European public assessment report (EPAR): Kefdensis, denosumab, Status: Opinion
- Human medicines European public assessment report (EPAR): Kyinsu, insulin icodec,semaglutide, Status: Opinion
- Human medicines European public assessment report (EPAR): Atropine sulfate FGK, atropine, Status: Opinion
- Human medicines European public assessment report (EPAR): Ponlimsi, denosumab, Status: Opinion
- EMA Management Board: highlights of October 2025 meeting
- Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 September - 2 October 2025
- Advice on end-of-year submission dates for type I variations in 2025
- A path to better include patients’ perspectives in the regulation of medicines
- New co-chairs elected for working parties for healthcare professionals and for patients and consumers
MedWatch Safety Alert RSS Feed
- Trividia Health, Inc. Initiates Voluntary Recall of Limited Number of TRUE METRIX® Blood Glucose Meters
- Endoscopic Aspiration Needle Recall: Olympus Removes Certain ViziShot 2 FLEX (19G) Needles Due to Potentially Deformed A-traumatic Tips
- What is a Medical Device Recall?
- Update on Alert: Infusion Set Performance Issue from BD
- Recall and Alert Resources
- What is an Early Alert?
- Blood and Plasma Warming Device Correction: 3M Company Issues Correction for Ranger Blood/Fluid Warming System
- Early Alert: Automated Impella Controller Purge Retainer Fixation Issue from Abiomed
- Olympus Issues Voluntary Recall for Specific Lots of ViziShot 2 FLEX (19G) EBUS -TBNA Needles
- Early Alert: TactiFlex Ablation Catheter Issue from Abbott
FDA Stay Informed on New Drugs
- CDER Quantitative Medicine Center of Excellence (QM CoE)
- Drugs@FDA Data Files
- Notable Approvals | Drugs
- What's New Related to Drugs
- FDA approves drug to treat idiopathic pulmonary fibrosis
- Novel Drug Approvals for 2025
- TKTX Numbing Cream USA - 702106 - 02/25/2025
- Generic Drug Facilities, Sites and Organization Lists
- EyeTech One, LLC - 712438 - 07/09/2025
- Revitalize Energy, Inc. - 712417 - 07/09/2025