NEWS
What's New Related to Drugs
FDA
2026/05/01Updated Monday through Friday
- Current and Resolved Drug Shortages and Discontinuations Reported to FDA
- Drug Firm Annual Registration Status
- Drug Firm Annual Registration Status Download File
- National Drug Code Directory
- NDC Unfinished Drugs Excluded Database File
- NDC Database Excluded Packages and Products
- Wholesale Distributor and Third-Party Logistics Providers Reporting
- Drugs@FDA Data Files
Updated Biweekly
May 1, 2026
April 23, 2026
April 17, 2026
- Draft Guidance: Establishing Impurity Specifications for Antibiotics
April 16, 2026
- CDER Statement: First FDA-Approved Treatment for Patients with Focal Segmental Glomerulosclerosis—A Rare Kidney Condition
- FDA Webinar on the RCT-DUPLICATE Initiative: Emulating Randomized Clinical Trials with Non-Randomized Real-World Data Studies
- Public Meeting: Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments
April 10, 2026
- Orange Book Approved Drug Products with Therapeutic Equivalence EvaluationsOrange Book Current Cumulative Supplement (updated)Additions/Deletions for Prescription and OTC Drug Product Lists (updated)Orange Book Data Files (compressed) (updated)Appendix A: Product Name Index (updated)Appendix B: Product Name Sorted by Applicant (updated)Appendix C: Uniform Terms (updated)Reference Listed Drugs by ANDA Reference Standard List (updated)Orange Book Patent Listing Dispute List (updated)
- Workshop: FDA/Center for Research on Complex Generics (CRCG) Workshop on Bioequivalence Innovations for Generic Oral Products: Biowaivers, Bridging, and Development for Oncology and Discontinued Products
April 7, 2026
- CDER Statement: FDA Approves First Generic Dapagliflozin Tablets
- Public Notifications: WAP Sensual Enhancement may be harmful due to hidden drug ingredientsCurcuflex may be harmful due to hidden drug ingredientsRM Joe may be harmful due to hidden drug ingredientsDINA Acido Hialurónico may be harmful due to hidden drug ingredientsKUKA FLEX CBD may be harmful due to hidden drug ingredientYeicob Ácido Hialurónico may be harmful due to hidden drug ingredients
- Public Workshop: Optimizing Pregnancy Registries
March 31, 2026
- FDA Identifies Cases of Serious Liver Injury in Patients Taking Tavneos (avacopan) for Severe Active Anti-neutrophil Cytoplasmic Autoantibody (ANCA)-associated Vasculitis
- New Safety Information or Potential Signals of Serious Risks Identified from the FDA Adverse Event Monitoring System (AEMS) (Updated)
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Summary
Want to know what's new on drugs from FDA? This page provides quick links to the latest on a variety of topics including: drug approvals, safety warnings, drug shortages, etc.