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FDA Grants Accelerated Approval to Multiple Myeloma Treatment

by Bruce Waldon | 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 Bruce Waldon | 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...

First-in-Class Non-Opioid Pain Reliever: Journavx

by Bruce Waldon | 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...

FDA Alert: Abiomed Impella Blood Pump Controller

by Bruce Waldon | Jul 8, 2025 | Alerts-Device, Class I Recalls, FDA Safety Communication, Med-Devices, MedWatch-System, Product Recalls, Product Safety

FDA Alert: Abiomed Impella Blood Pump Urgent Recall Controller may fail to detect the Impella device Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact Abiomed Impella blood pump controllers...

China Implements a Ban on European Medical Devices

by Bruce Waldon | Jul 8, 2025 | Global-RA, Industry Information, Industry News

China Retaliates Against European Union Device Manufacturers Imposes a ban on European medical devices Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact Growing China-EU Trade Conflict The medical...
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