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...

FDA Cracks Down on Illegally Marketed 7-OH Products

by MDP Staff | Jul 16, 2025 | Alerts, Alerts-Pharma, Consumer Safety, FDA Warning letters, Industry News, Unapproved Drugs

FDA Cracks Down on Companies Illegally Marketing 7-OH Products Products that contain 7-hydroxymitragynine (7-OH) Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact Unapproved drugs sold online and...

Sterile Drug Manufacturing Violations at Daewoo Pharmaceutical

by MDP Staff | Jul 16, 2025 | Alerts, Alerts-Pharma, FDA Enforcement, FDA Warning letters, Industry News, Pharmaceuticals, Product Safety

FDA Warning Letter to Daewoo Pharmaceuticals Co., Ltd. Multiple cGMP violations cited Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact FDA Cracks Down on Sterile Drug Manufacturing Violations The...

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...