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 | 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...
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...
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...
