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

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.