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Latest posts
Last updated 3 days ago
Antifungal Susceptibility Test Interpretive Criteria
3 days ago
Antifungal Susceptibility Test Interpretive Criteria
Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)
3 days ago
Learn about the FDA's Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)...
Completed BsUFA III Deliverables
4 days ago
Since the passage of the Biosimilar User Fee Act (BsUFA) in 2012...
October - December 2024 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
4 days ago
This report lists potential signals of serious risks/new safety information that were...
Novel Drug Approvals for 2025
4 days ago
Innovative drugs often mean new treatment options for patients and advances in...
Resource Capacity Planning and Modernized Time Reporting
4 days ago
FDA is making optimal use of its financial resources to maximize its...
Sani-Care Salon Products, Inc. - 673747 - 04/24/2024
4 days ago
CGMP/Finished Pharmaceuticals/Adulterated
FDA approves durvalumab for muscle invasive bladder cancer
7 days ago
On March 28, 2025, the Food and Drug Administration approved durvalumab (Imfinzi...
FDA Approves Novel Treatment for Hemophilia A or B, with or without Factor Inhibitors
7 days ago
Today, the U.S. Food and Drug Administration approved a novel treatment for...
Scientific Public Private Partnerships and Consortia
7 days ago
Find out how CDER works with partners and consortia to identify science...
What's New Related to Drugs
7 days ago
Want to know what's new on drugs from FDA? This page provides...
FDA expands Pluvicto’s metastatic castration-resistant prostate cancer indication
7 days ago
On March 28, 2025, the Food and Drug Administration expanded the indication...