New Human Medicines: RSS Feed from EMA
- Human medicines European public assessment report (EPAR): Ekterly, sebetralstat, Status: Opinion
- Human medicines European public assessment report (EPAR): Elevidys, delandistrogene moxeparvovec, Status: Opinion
- Human medicines European public assessment report (EPAR): Bilprevda, denosumab, Status: Opinion
- Human medicines European public assessment report (EPAR): Jelrix, autologous cartilage-derived articular chondrocytes, in-vitro expanded, Status: Opinion
- Human medicines European public assessment report (EPAR): Eyluxvi, aflibercept, Status: Opinion
- Human medicines European public assessment report (EPAR): Aplidin, plitidepsin, Status: Application withdrawn
- Human medicines European public assessment report (EPAR): Yeytuo, lenacapavir, Status: Opinion
- Human medicines European public assessment report (EPAR): Nurzigma, pridopidine, Status: Opinion
- Human medicines European public assessment report (EPAR): Kisunla, donanemab, Status: Opinion
- Human medicines European public assessment report (EPAR): Usrenty, ustekinumab, Status: Opinion
- Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 July 2025
- First reformulation of an inhaled medicine with environmentally friendly gas propellant
- New injection for easier prevention of HIV infection in the EU and worldwide
- New treatment for Niemann-Pick type C disease
- EMA Paediatric Committee elects Sabine Scherer as its new chair
MedWatch Safety Alert RSS Feed
- Disposable Surgical Stapler Cartridge Correction: Ethicon Endo-Surgery, LLC Issues Correction for Endopath Echelon to Address Inadvertent Lockout During Surgical Procedures
- Arterial Cannula Recall: Edwards Lifesciences Removes Arterial Cannula due to Risk of Wire Exposure
- Mobile Lift Component Recall: Baxter Healthcare Corporation Removes Mobile Lift Component due to Risk of Improper Attachment
- Medical Procedure Kits Correction: Medline Industries, LP Issues Correction for Medline Craniotomy Kits Containing Codman Disposable Perforators Due to Risk for Device Disassembly
- Early Alert: Infusion Pump Issue from Baxter
- Manual Resuscitator Recall: SunMed Holdings, LLC Removes Adult Manual Resuscitator Devices Due to Incorrect Assembly of B/V Filter
- Continuous Ventilator (Respirator) Correction: Maquet Critical Care AB Updates Use Instructions for Servo Ventilator Systems Due to Risk of Inaccurate Compliance Measurement Leading to Improper Tidal Volume Delivery in Neonatal Patients
- Applicator Recall: Integra LifeSciences Removes MicroMyst Applicators Due to Potential Sterility Concerns
- Early Alert: Microbore Extension Set Issue from B. Braun Medical Inc.
- Portable Oxygen Concentrator Car Adapter Recall: Drive DeVilbiss Healthcare Removes iGo DV6X-619 DC Car Adapter Due to Cord Possibly Becoming Hot to the Touch and/or Melting While Being Used
FDA Stay Informed on New Drugs
- Generic Drug User Fee Amendments
- Drugs@FDA Data Files
- Drug Compliance Programs
- What's New Related to Drugs
- FDA is requiring opioid pain medicine manufacturers to update prescribing information regarding long-term use
- Drug Safety Communications
- Emergency Use Authorizations for Drugs and Non-Vaccine Biological Products
- Recently Issued Guidance Documents
- Generic Drug Research Priorities & Projects
- Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs