What's New Related to Drugs
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
September 4, 2026
- FDA grants accelerated approval to camizestrant with a CDK4/6 inhibitor for ESR1-Mutated HR-positive, HER2-negative locally advanced or metastatic breast cancer
- Final Guidance: Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates
- Public Notification: ZUBB Dietary Supplement may be harmful due to hidden ingredient
September 3, 2026
- Press Release: FDA Approves First Drug to Treat Alexander Disease
- CDER Statement: FDA Update on Estradiol Transdermal Patch Availability
September 2, 2026
- Public Notification: MAXMAN Coffee may be harmful due to hidden drug ingredients
September 1, 2026
- Drug Safety Communication: FDA Adds Boxed Warning to Labeling for Ferric Carboxymaltose Injection (Injectafer) to Describe Risk of Low Phosphate Levels
- Draft Guidance: Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling
August 31, 2026
- CDER Statement: International Collaboration to Advance New Testing Methods That Reduce Reliance on Horseshoe Crab Blood
- FDA Approves Treatment for Essential Thrombocythemia
August 28, 2026
- FDA Approves First Drug of Its Kind for Polycythemia Vera, a Rare Blood Disorder
- FDA Approves Stelara for Pediatric Ulcerative Colitis
August 27, 2026
- FDA Approves First Oral Drug Indicated to Treat Dermatomyositis in Adults
- FDA reminds compounders not to use dietary supplement grade glutathione for injectables
August 25, 2026
- FDA Approves Drug to Treat HIV Infection in Newborns
- Public Notification: Qu Feng Huo Lou Dan may be harmful due to hidden ingredient
- FDA Approves First Drug for Warm Autoimmune Hemolytic Anemia
August 24, 2026
- October 14 Webinar: Navigating the FDA Bayesian Draft Guidance: Design, Analysis, and Review Considerations
August 21, 2026
- CDER Statement: FDA Publishes New Product-Specific Guidances to Facilitate Generic Drug Development
- Final Guidance: Evaluation of Therapeutic Equivalence
August 18, 2026
- Public Notifications:
August 17, 2026
- Draft Guidance: Determining Whether to Submit an ANDA or a 505(b)(2) Application
August 14, 2026
- September 9 Public Meeting: Addressing the Public Health Effects of Opioid Medications
- 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)
August 13, 2026
- FDA grants accelerated approval to iberdomide with daratumumab and hyaluronidase-fihj and dexamethasone for multiple myeloma
- Draft Guidance: Container Closure Systems for Human Drugs and Biological Products
- September 16, 2026 Public Meeting on the Recommendations for Reauthorization of the Prescription Drug User Fee Act (PDUFA)
August 12, 2026
- Public Notifications:
August 10, 2026
August 6, 2026
- FDA grants accelerated approval to vusolimogene oderparepvec-wtpg in combination with nivolumab for melanoma
- September 23 Webinar: Communicating Drug Interaction and QTc Information in the U.S. Prescribing Information
July 31, 2026
- FDA approves lutetium Lu 177 vipivotide tetraxetan with androgen receptor pathway inhibitor therapy for metastatic androgen pathway modulation-naïve or -sensitive prostate cancer
- September 10 Workshop: Advancing Generic Drug Development: Modernizing Bioequivalence Approaches for Topical & Transdermal Products
- Draft Guidance: Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs
- Final Guidance: Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs
- Draft Guidance: Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts
July 29, 2026
July 28, 2026
July 24, 2026
- FDA approves zidesamtinib for ROS1-positive non-small cell lung cancer
- Notable Approval: FDA Approves First Nonprescription Fixed-Dose Combination of Acetaminophen and Naproxen Sodium for 12-Hour Pain Relief
July 23, 2026
- Public Notification: Kangaroo Intense Venus 3000 may be harmful due to hidden drug ingredient
- September 23-24 Workshop: FDA/Center for Research on Complex Generics (CRCG) Workshop on Navigating the GLP-1 Generic Drug Pathway