FDA Streamlines Biosimilar Development to Reduce Drug Costs

by Bruce Waldon | Mar 10, 2026 | Biologics-information, Biosimilars, FDA Approvals, FDA_Innovation, Product-Innovation, US-FDA

FDA Regulatory Innovation Streamlining the development of biosimilars Home About Consumer Food and Beverage Supplements Regulatory Medical Devices Pharma Biologics Combination Products Veterinary AI Quality QMSR Central News Enforcement Alerts Innovation Contact FDA...

FDA Approves Novel Device for Pancreatic Cancer Treatment

by Bruce Waldon | Mar 4, 2026 | FDA Approvals, Med-Devices, New devices, Product-Innovation, US-FDA

Medical Device Innovation Optune Pax treats pancreatic cancer with TTFields therapy Home About Consumer News Food and Beverage Supplements Cosmetics Regulatory Medical Devices Pharma Biologics Combination Products In Vitro Diagnostics Veterinary AI Quality QMSR...

The FDA Orphan Drug Program

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...

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...