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...

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

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...

China Implements a Ban on European Medical Devices

by Devices and Pharma | 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...

GE HealthCare Anesthesia Systems Recall Due to Ventilation Risk

by Devices and Pharma | Jul 7, 2025 | Alerts-Device, Class I Recalls, FDA Safety Communication, Industry News, Product Recalls, Products_Devices

GE HealthCare Anesthesia Systems Recall potentially life-threatening risk in Volume Control Ventilation (VCV) mode Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact GE Carestation Anesthesia...

FDA Approves DATROWAY® Breast Cancer Treatment

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...