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- Draft Guidance: Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs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- Draft Guidance: Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts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
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.
