RSS Feed from EMA on New Human Medicines
- Human medicines European public assessment report (EPAR): Cenrifki, tolebrutinib, Status: Opinion
- Human medicines European public assessment report (EPAR): Rexatilux, ranibizumab, Status: Opinion
- Human medicines European public assessment report (EPAR): Redemplo, plozasiran, Status: Opinion
- Human medicines European public assessment report (EPAR): Palbociclib Viatris, palbociclib, Status: Opinion
- Human medicines European public assessment report (EPAR): Itvisma, onasemnogene abeparvovec, Status: Opinion
- Human medicines European public assessment report (EPAR): Jelrix, autologous cartilage-derived articular chondrocytes, in-vitro expanded, Status: Application withdrawn
- Human medicines European public assessment report (EPAR): Imdylltra, tarlatamab, Status: Opinion
- Human medicines European public assessment report (EPAR): Adstiladrin, nadofaragene firadenovec, Status: Opinion
- Human medicines European public assessment report (EPAR): Zepzelca, lurbinectedin, Status: Opinion
- Human medicines European public assessment report (EPAR): Bopediat, furosemide, Status: Opinion
- Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 April 2026
- New medicine to reduce triglycerides in adults with familial chylomicronaemia syndrome
- EMA business hours over King's Day and Labour Day, 27 April and 1 May
- Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 14-16 April 2026
- EMA recommends authorisation of first veterinary vaccine using RNA technology
MedWatch Safety Alert RSS Feed
- Early Alert: Arrow International Removes Dialysis Catheter Kits Containing Merit Medical Splittable Sheath Introducers
- Early Alert: Automated Compounding System Issue from Omnicell
- Early Alert: Convenience Kit Issue from Aligned Medical Solutions
- Cranial Drill Recall: Integra LifeSciences Recalls Codman Disposable Perforators Due to Risk of Device Disassembly
- Insulin Pump Correction: Tandem Diabetes Care Issues Correction for Tandem Mobi Insulin Pumps
- Windstone Medical Packaging dba Aligned Medical Solutions Issues Nationwide Recall of Namic Angiographic Rotating Adapter 10CC Control Syringe Placed into the Following Kits; AMS6908E Angio Pack, and AMS6908F Angio Pack
- Early Alert: Convenience Kit Issue from Medical Action Industries
- Early Alert: Convenience Kit Issue from American Contract Systems
- Reconstruction Prosthesis Correction: Stryker Updates Use Instructions for Patient-Fitted TMJ Implants
- Ventilator Tubing Correction: Percussionaire Corporation Updates Use Instructions for Phasitron In-Line Valve
FDA Stay Informed on New Drugs
- GDUFA IV: Fiscal Years 2028 – 2032
- Over-The-Counter Monograph Drug User Fee Program (OMUFA)
- Postmarketing Requirements and Commitments: Reports
- Generic Drug User Fee Amendments
- Drugs@FDA Data Files
- Untitled Letters
- Digital Health Technologies (DHTs) for Drug Development
- Timeline of Selected FDA Activities and Significant Events Addressing Substance Use and Overdose Prevention
- List of Active Radioactive Drug Research Committee (RDRC) Sites
- Activities Report of the Generic Drug Program | FDARA Title VIII Sections 807 and 805