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Latest posts
Last updated 1 day ago
Economic Assistance and Incentives for Drug Development
1 day ago
Small Business Assistance: Economic Assistance and Incentives for Drug Development
FDA approves zenocutuzumab-zbco for advanced, unresectable or metastatic cholangiocarcinoma
1 day ago
On May 8, 2026, the Food and Drug Administration approved zenocutuzumab-zbco (Bizengri...
Search for Regulatory References | Drugs
1 day ago
Find information on drug development, applications, submissions, manufacturing & quality, safety, labeling...
FDA Grants Seventh Approval under the National Priority Voucher Pilot Program
1 day ago
FDA issued an approval for Bizengri (zenocutuzumab-zbco), a drug that treats NRG1...
Drug Development Tool (DDT) Qualification Programs
1 day ago
Information about the mission and objectives of FDA’s Drug Development Tool (DDT)...
Communicating Benefit and Risk Information
1 day ago
FDA Drug Info Rounds pharmacists talk about the benefit risk balance, and...
Drug Promotion
1 day ago
FDA Drug Info Rounds pharmacists discuss the many elements surrounding the marketing...
Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and Prevention
1 day ago
Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and Prevention
Postapproval Pregnancy Safety Studies
1 day ago
This guidance provides sponsors and investigators with recommendations on how to design...
Pulmonary Tuberculosis: Developing Drugs for Treatment
1 day ago
The purpose of this guidance is to assist sponsors in the clinical...
Rare Disease News, Events & Reports
2 days ago
Learn more about recent news and events related to rare diseases and...
Learning and Education to ADvance and Empower Rare Disease Drug Developers (LEADER 3D)
2 days ago
As part of the Accelerating Rare disease Cures (ARC) Program, CDER’s Rare...