May 13, 2026
- Draft Guidance: Development of Non-Opioid Analgesics for Acute Pain (Updated)
May 11, 2026
- CDER Statement: FDA Alerts Health Care Providers and Patients about Increased Risk of New Blood Cancers with Tazverik (tazemetostat) Use; Sponsor to Voluntarily Withdraw Product from Market
- Workshop: Advancing Generic Drug Development: Bioequivalence Challenges for Patient-Centric Oral Formulations
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.
