- HMPC: overview of assessment work - priority list
- Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 March 2025
- Human medicines European public assessment report (EPAR): Xoanacyl, ferric citrate coordination complex, Status: Opinion
- Summary of opinion: Opdivo, 27/03/2025 Positive
- Summary of opinion: Calquence, 27/03/2025 Positive
- Summary of opinion: Tremfya, 27/03/2025 Positive
- Summary of opinion: Tevimbra, 27/03/2025 Positive
- EMA concludes review of weight management medicine Mysimba
- Summary of opinion: Pemazyre, 27/03/2025 Negative
- Withdrawn application: Amyvid, 26/02/2025
- Human medicines European public assessment report (EPAR): Qoyvolma, ustekinumab, Status: Opinion
- Human medicines European public assessment report (EPAR): Jubereq, denosumab, Status: Opinion
- Human medicines European public assessment report (EPAR): Osvyrti, denosumab, Status: Opinion
- Summary of opinion: Flucelvax, 27/03/2025 Positive
- Human medicines European public assessment report (EPAR): Ryjunea, Status: Opinion
- Know Which Medication Is Right for Your Seasonal Allergies
- Sani-Care Salon Products, Inc. - 673747 - 04/24/2024
- Glenmark Pharmaceuticals Inc., USA Issues Voluntary Nationwide Recall for Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K Due to Failed Dissolution
- Report | Drug Shortages: Root Causes and Potential Solutions
- FDA approves treatment for chronic inflammatory demyelinating polyneuropathy (CIDP) in adults
- Facilitating Generic Drug Product Development through Product-Specific Guidances - 04/25/2024
- Modernizing the New Drugs Regulatory Program
- FDA grants accelerated approval to adagrasib with cetuximab for KRAS G12C-mutated colorectal cancer
- Public Workshop: Best Practices for Meeting Management Under PDUFA VII - 07/22/2024
- Center for Drug Evaluation and Research National Survey on Numerical Claims in Prescription Drug Advertising
- Infla-650 contains hidden drug ingredients
- Cefdinir - Oral products
- Considerations in Demonstrating Interchangeability With a Reference Product: Update
- Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection
- FDA updates guidance on interchangeability
- Field Safety Notices: 17 to 21 March 2025
- MHRA Safety Roundup: March 2025
- Suzhou Surgicare disposable Hysteroscopy Sheath– Recall due to withdrawn CE certificate, (DSI/2025/001)
- Field Safety Notices: 10 to 14 March 2025
- Class 4 Medicines Defect Notification: Azithromycin 250 mg Capsules, EL(25)A/11
- Field Safety Notices: 3 to 7 March 2025
- Class 2 Medicines Recall: Boots Paracetamol 500 mg tablets (16s), EL(25)A/10
- Class 2 Medicines Recall: Sun Pharmaceutical Industries Europe B.V., Pemetrexed 1000MG/100ML (10mg/ml) & 800MG/ML (8mg/ml) Infusion bag, EL(25)A/09
- Field Safety Notices: 24 to 28 February 2025
- Class 3 Medicines Recall: Azacitidine 100 mg/vial and 150 mg/vial Powder for Suspension for Injection, EL(25)A/08
- Field Safety Notices: 17 to 21 February 2025
- Class 3 Medicines Recall: Glucophage SR 500 mg, 750mg and 1000mg Prolonged-release Tablets, EL(25)A/07
- Field Safety Notices: 10th - 14th February 2025
- Field Safety Notices: 3 to 7 February 2025
- Class 4 Medicines Notification: Lansoprazole Gastro-resistant Hard Capsules 15mg, EL(25)A/06
FDA
- Know Which Medication Is Right for Your Seasonal Allergies
- Sani-Care Salon Products, Inc. - 673747 - 04/24/2024
- Glenmark Pharmaceuticals Inc., USA Issues Voluntary Nationwide Recall for Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K Due to Failed Dissolution
- Report | Drug Shortages: Root Causes and Potential Solutions
- FDA approves treatment for chronic inflammatory demyelinating polyneuropathy (CIDP) in adults
- Facilitating Generic Drug Product Development through Product-Specific Guidances - 04/25/2024
- Modernizing the New Drugs Regulatory Program
- FDA grants accelerated approval to adagrasib with cetuximab for KRAS G12C-mutated colorectal cancer
- Public Workshop: Best Practices for Meeting Management Under PDUFA VII - 07/22/2024
- Center for Drug Evaluation and Research National Survey on Numerical Claims in Prescription Drug Advertising
- Infla-650 contains hidden drug ingredients
- Cefdinir - Oral products
- Considerations in Demonstrating Interchangeability With a Reference Product: Update
- Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection
- FDA updates guidance on interchangeability
