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

May 8, 2026

• FDA approves zenocutuzumab-zbco for advanced, unresectable or metastatic cholangiocarcinoma
• Orange Book
  • Approved Drug Products with Therapeutic Equivalence Evaluations
  • Orange Book Current Cumulative Supplement (updated)
  • Additions/Deletions for Prescription and OTC Drug Product Lists (updated)
  • Orange Book Data Files (compressed) (updated)
  • Reference Listed Drugs by ANDA Reference Standard List (updated)
  • Orange Book Patent Listing Dispute List (updated)
• Final guidance: Postapproval Pregnancy Safety Studies
• Final guidance: Pulmonary Tuberculosis: Developing Drugs for Treatment
• Final guidance: Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and Prevention

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.