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

July 1, 2026

• Public Notification: MAGNUM Brand products may be harmful due to hidden drug ingredients
• Final Guidance: Submitting Next-Generation Sequencing Data to the Division of Antiviral Products

June 30, 2026

• FDA approves allogeneic regulatory T cell-based immunotherapy with HSPC and T cells-vldq for use in matched donor hematopoietic stem cell transplantation for adults with hematologic malignancies
• January - March 2026 | New Safety Information or Potential Signals of Serious Risks Identified by the FDA Adverse Event Monitoring System (AEMS)

June 24, 2026

• FDA approves sacituzumab govitecan-hziy as monotherapy and in combination with pembrolizumab for first-line treatment of triple-negative breast cancer
• FDA Approves First Treatment Shown to Reduce the Risk of Acute Pancreatitis in Adults with Severe Hypertriglyceridemia
• FDA approves palbociclib with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of HR-positive, HER2-positive metastatic breast cancer
• Public Notification: PRE-FORMANCE BLACK may be harmful due to hidden ingredient

June 22, 2026

• Draft Guidance: Master Protocols for Drug and Biological Product Development
• Draft Guidance: Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products
• Draft Guidance: Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials

June 18, 2026

• Final Guidance: Submitting Clinical Trial Datasets to Evaluate the Impact of Immunogenicity on the Pharmacokinetics of a Drug

June 17, 2026

• FDA approves first oral carbapenem therapy for complicated urinary tract infections

June 12, 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)
  • Reference Listed Drugs by ANDA Reference Standard List (updated)
  • Orange Book Patent Listing Dispute List (updated)
• Draft Guidance: Forms FDA 3542a and FDA 3542: Questions and Answers
• FDA approves belzutifan with pembrolizumab for adjuvant treatment of renal cell carcinoma
• FDA approves capivasertib with abiraterone and prednisone for PTEN-deficient androgen pathway modulation-naïve or -sensitive prostate cancer
• FDA Approves Drug for Pediatric Stage 3 Type I Diabetes

June 10, 2026

• Public Notifications:
  • Business Pill may be harmful due to hidden drug ingredient
  • Branch Manager for Men may be harmful due to hidden drug ingredient
• Webinar: ClinicalTrials.gov: Essentials for Academic Medical Centers
• Drug Safety Communication: FDA Approves Labeling Changes for Over-the-Counter (OTC) Weight Loss Drug alli (Orlistat) to Warn of Risk of Kidney Stones and Kidney Injury

June 5, 2026

• Public Notification: Pink Pussycat Brand products may be harmful due to hidden drug ingredients

June 4, 2026

• Public Notifications:
  • Juicy AF! may be harmful due to hidden drug ingredient
  • Lipofit Extreme 2.0 Fat Burner may be harmful due to hidden drug ingredients
• Final Guidance: Certain Postapproval Requirements and Resources for ANDAs

June 3, 2026

• CDER Statement: FDA Accepts First In Silico Drug Development Tool Under ISTAND Program to Help Predict Drug-Induced Liver Injury

June 2, 2026

• Draft Guidance: Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers
• Final Guidance: M15 General Principles for Model-Informed Drug Development

May 29, 2026

• Public Notifications: 
  • Tawon Liar contains hidden drug ingredient (updated)
  • Sensual Miracle Honey may be harmful due to hidden drug ingredients
  • Baipho Herbs Tea Drink may be harmful due to hidden drug ingredient
  • Erectus Plus may be harmful due to hidden drug ingredients
  • X10 Natural Enhancement Supplement may be harmful due to hidden drug ingredients
  • Big Dick Energy! may be harmful due to hidden drug ingredient
• Final Guidance: Q8, Q9, and Q10 Questions and Answers (R5) (updated)

May 28, 2026

• FDA approves durvalumab in combination with Bacillus Calmette-Guerin for high-risk non-muscle invasive bladder cancer
• Final Guidance: Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application
• Final Guidance: Statistical Approaches to Establishing Bioequivalence

May 27, 2026

• Public Notification: biQ-FEL may be harmful due to hidden drug ingredients
• FDA approves pivekimab sunirine-pvzy for blastic plasmacytoid dendritic cell neoplasm, an ultra-rare hematologic malignancy

May 22, 2026

• FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic triple-negative breast cancer

May 20, 2026

• Webinar: Eco-NAMs Webinar Series | In Silico Approaches to Replace Acute Fish Toxicity

May 15, 2026

• Alert: FDA warns consumers not to use expired Amazon Basic Care Levonorgestrel 1.5 mg
• FDA approves two separate indications for fam-trastuzumab deruxtecan-nxki in HER2-positive early-stage breast cancer
• FDA approves first interchangeable biosimilars to Simponi and Simponi Aria (golimumab) to treat rheumatoid arthritis and ulcerative colitis
• Public Notification: Sâm Xương Khớp Ông Tiên may be harmful due to hidden drug ingredients
• FDA approves atezolizumab for adjuvant treatment of muscle invasive bladder cancer in patients with molecular residual disease