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FDA Cracks Down on Insightra Medical

by MDP Staff | Jul 16, 2025 | Alerts, Cardiovascular, Device Warning Letters, FDA Enforcement, FDA Public Information, FDA Warning letters, Industry News, Med-Devices, QSR, Safety

FDA Cracks Down on Insightra Medical Unapproved use and serious quality violations found Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact Warning Letter Cites a Number of Serious Violations In a...

FDA Cracks Down on Illegally Marketed 7-OH Products

by MDP Staff | Jul 16, 2025 | Alerts, Alerts-Pharma, Consumer Safety, FDA Warning letters, Industry News, Unapproved Drugs

FDA Cracks Down on Companies Illegally Marketing 7-OH Products Products that contain 7-hydroxymitragynine (7-OH) Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact Unapproved drugs sold online and...

Sterile Drug Manufacturing Violations at Daewoo Pharmaceutical

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...

Avanos Recalls Ballard Closed Suction Systems

by Devices and Pharma | Jul 10, 2025 | Alerts-Device, Class I Recalls, FDA Safety Communication, Industry News, Med-Devices, MedWatch-System, Product Recalls, US-FDA

Avanos Recalls Ballard Closed Suction Systems Due to sterilization failure Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact May result in non-sterile devices Avanos Medical, Inc. is recalling its...

FDA Grants Accelerated Approval to Multiple Myeloma Treatment

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...

FDA Approves Alhemo for Patients with Hemophilia A or B

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...
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