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 25, 2025
- Public Notifications:
- FDA Approves Third Treatment for Fibrodysplasia Ossificans Progressiva
- FDA Approves Drug to Treat Idiopathic Nephrotic Syndrome in Patients 2 Years and Older
September 24, 2026
September 23, 2026
September 18, 2026
- FDA approves imlunestrant in combination with abemaciclib for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer
- FDA Approves Therapy to Treat Ataxia in Patients with Ataxia-Telangiectasia, a Rare Genetic Disorder
September 16, 2026
September 15, 2026
- Public Notifications:
- Drug Safety Communication: FDA Approves Additional Information in Labeling for Kybella (Deoxycholic Acid) Injection Warning of Adverse Reactions Associated with Unapproved Use
September 11, 2026
- FDA Approves First Therapy to Target Muscle Loss in Spinal Muscular Atrophy
- 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)
- FDA approves first treatment for children aged 4-11 years with APDS, a rare genetic disorder of the immune system
September 9, 2026
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 Luo 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