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FDA “PreCheck” Program to Boost U.S. Drug Manufacturing

by MDP Staff | Aug 7, 2025 | FDA Public Information, FDA_Innovation, Industry Information, Industry News, New Pharma Products, Pharmaceuticals

“PreCheck” Program to Boost U.S. Drug Manufacturing Program supports facilities certification and drug submissions Home About Consumer Medical Devices Medical Device Warning Letters Pharma Pharma Warning Letters Biologics Biologics Warning Letters AI Regulatory...

The FDA Orphan Drug Program

by Bruce Waldon | 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 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 Approves DATROWAY® Breast Cancer Treatment

by Bruce Waldon | 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...
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