Delivery Method: VIA UPS Reference #: 320-25-17 Product: Drugs Recipient: Recipient Name Mr. Ernesto Leonelli Recipient Title CEO Eurosirel S.P.A Viale Europa 3020090 Cusago MIItaly Issuing […]

Delivery Method: VIA UPS Reference #: 320-25-16 Product: Drugs Recipient: Recipient Name Mr. Zhan Libin Recipient Title General Manager Hangzhou Huiji Biotechnology Co., Ltd. No. 3 […]

Product: Drugs Recipient: Recipient Name Rahul Patel Recipient Title President Centura Pharmaceuticals Inc 24718 State Road 54CLutz, FL 33559United States [email protected] Issuing Office: Center for Drug […]

Docket Number: FDA-2024-D-4643 Issued by: Guidance Issuing Office Oncology Center of Excellence Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This draft […]

GUIDANCE DOCUMENT Draft Level 1 Guidance Not for implementation. Contains non-binding recommendations. This guidance is being distributed for comment purposes only. Content current as of: 11/25/2024 […]

Background Prescribing information (PI) included in prescription drug labeling is FDA’s primary tool for communicating a summary of the essential scientific information needed for the safe […]

UPDATE: On November 22, 2024, the FDA announced the final withdrawal of the approval of sacituzumab govitecan-hziy (Trodelvy) for adult patients with locally advanced or metastatic urothelial […]

On This Page Date: January 22, 2025 Time: 1:00 PM – 3:00 PM ET AGENDA Visit CDER Small Business and Industry Assistance Page ABOUT THIS EVENT […]

Action  The U.S. Food and Drug Administration has approved Attruby (acoramidis) to treat adults with cardiomyopathy (disorder that affects heart muscle) of wild-type or variant (hereditary) […]