On August 6, 2024, the Food and Drug Administration approved vorasidenib (Voranigo, Servier Pharmaceuticals LLC), an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor, for adult […]

[8/6/2024] FDA is warning consumers to not purchase or use certain inhalants, which are unapproved drugs marketed to promote alertness and boost energy. These products primarily […]

This dataset provides a listing of all New Molecular Entities (NMEs) approved from 1985 – 2023 and regulated by the Center for Drug Evaluation and Research […]

For Immediate Release: August 06, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  On Monday, […]

Summary Company Announcement Date: August 05, 2024 FDA Publish Date: August 06, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Elevated endotoxin levels Company […]

Delivery Method: VIA UPS Reference #: 320-24-54 Product: Drugs Recipient: Recipient Name Mr. Honghui Cheng Recipient Title Legal Representative and Chairman of the Board Guangzhou Baiyunshan […]

Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Mr. Glenn E. Mouser Recipient Title President Omega Tech Labs LLC 5858 W. Franklin RoadBoise, ID […]

Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Mr. Ankur J. Shah Recipient Title President Velocity Pharma LLC 26 Blueberry Ct.Melville, NY 11747United States […]

The FDA Compounding Quality Center of Excellence provides training anytime, anywhere at no cost. Each course provides continuing education (CE) credits for pharmacists, pharmacy technicians, physicians […]