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...
by Devices and Pharma | Mar 25, 2025 | Industry Information, Med-Devices, Pharmaceuticals, Reg_Information, Reg_Science, Regulatory_Info
The Role of a Regulatory Professional A complex combination of knowledge, skills, and ability Home Science Function The Role of a Regulatory Professional RAPS Labeling Medical Device Labeling FDA QMSR Central EU IMDRF Training Services Topics Risk Management Contact...
by Devices and Pharma | Feb 18, 2025 | Consumer Information, New Drugs, New Pharma Products, Pharmaceuticals
FDA Announces First Eliquis Generics Consumer-oriented medical device and pharmaceutical information Home FDA Pharma Biologics Approvals Shortages Safety Alerts Recalls Warning Letters Contact Generic Eliquis Editor’s note: FDA originally announced the approval...
