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- Draft Guidance: Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling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
This report displays final approvals and tentative approvals of original and supplemental applications for the two days beginning on the earliest date listed below. Some approvals may be added to the Drugs@FDA database after this time span. For comprehensive approval reports, please use the monthly "All Approvals" report on Drugs@FDA.
