May 13, 2026

• FDA approves oral combination of decitabine and cedazuridine tablets with venetoclax for newly diagnosed acute myeloid leukemia
• FDA grants accelerated approval to sonrotoclax for relapsed or refractory mantle cell lymphoma
• Draft Guidance: Development of Non-Opioid Analgesics for Acute Pain (Updated)
• Draft Guidance: Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework (Updated)
• Draft Guidance: Development of Local Anesthetic Drug Products With Prolonged Duration of Effect (Updated)
• Draft Guidance: Stimulant Use Disorders: Developing Drugs for Treatment (Updated)
• Draft Guidance: Development of Non-Opioid Analgesics for Chronic Pain (Updated)
• Drug Trials Snapshots: Forzinity

May 11, 2026

• FDA News Release: FDA Advances Drug Repurposing to Address Unmet Medical Needs
• 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.