by MDP Staff | Jul 16, 2025 | Alerts, Alerts-Pharma, FDA Enforcement, FDA Warning letters, Industry News, Pharmaceuticals, Product Safety
FDA Warning Letter to Daewoo Pharmaceuticals Co., Ltd. Multiple cGMP violations cited Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact FDA Cracks Down on Sterile Drug Manufacturing Violations The...
by Devices and Pharma | Jul 9, 2025 | Consumer Information, FDA_Innovation, FDA_Programs, New Pharma Products, Orphan Drugs, Pharmaceuticals, Product-Innovation, US-FDA
FDA's Orphan Drugs Program Development of drugs for rare diseases Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact Incentives for Rare Disease Drug Development The FDA’s Orphan Drug Program was...
by Devices and Pharma | Jul 9, 2025 | FDA Approvals, Industry News, New Drugs, New Pharma Products, Pharmaceuticals, Product-Innovation, US-FDA
FDA Grants Accelerated Approval to Lynozyfic A bispecific T-cell engager that targets BCMA on myeloma cells and CD3 on T-cells Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact For hard-to-treat...
by Devices and Pharma | Jul 8, 2025 | FDA Approvals, Industry News, New Drugs, New Pharma Products, Pharmaceuticals, US-FDA
FDA Approves Alhemo for Patients with Hemophilia Routine prophylaxis to prevent or reduce bleeding Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact For Patients with Hemophilia A or B with...
by Devices and Pharma | Jul 8, 2025 | Industry News, New Drugs, New Pharma Products, Opioid Crisis, Pharmaceuticals
FDA Approves First-in-Class Non-Opioid Pain Reliever Journavx (suzetrigine) – a first-in-class, non-opioid analgesic Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact A new non-opioid pain...
by Devices and Pharma | Jul 7, 2025 | FDA Approvals, FDA_Innovation, Industry News, New Drugs, New Pharma Products, Pharmaceuticals, Product-Innovation, US-FDA
FDA Approves DATROWAY® for Advanced HR+/HER2- Breast Cancer Trop-2-directed antibody-drug conjugate Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact A new breast cancer treatment option The United...
