What's New Related to Drugs

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Updated 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

• Competitive Generic Therapy Approvals

February 5, 2026

• Safety labeling update for capecitabine and fluorouracil (5-FU) on risks associated with dihydropyrimidine dehydrogenase (DPD) deficiency
• Draft Guidance: E22 General Considerations for Patient Preference Studies

February 4, 2026

• Drug Trials Snapshots: LEROCHOL
• Drug Trials Snapshots: WAYRILZ

February 2, 2026

• Umary contains hidden drug ingredients
• Drug Trials Snapshots: REDEMPLO

January 27, 2026

• FDA approves daratumumab and hyaluronidase-fihj with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma

January 21, 2026

• Drug Trials Snapshots KYGEVVI
• FDA Announces PreCheck Implementation Roadmap

January 20, 2026

• Draft Guidance: M4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality

January 13, 2026

• FDA Requests Removal of Suicidal Behavior and Ideation Warning from Glucagon-Like Peptide-1 Receptor Agonist (GLP-1 RA) Medications

January 12, 2026

• Draft Guidance: Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products

January 9, 2026

• Orange Book
  • Approved Drug Products with Therapeutic Equivalence Evaluations
  • Orange 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)

January 5, 2026

• FDA approves therapy for rare blood disorder in pediatric patients 12 years and older
• FDA approves first oral treatment for anemia in thalassemia, an inherited blood disorder
• FDA approves first drug to treat serious complication of stem cell transplant