July 13, 2026

• September 14 Public Hearing: Considerations for Potential Future Therapeutic Use of Psychedelic Drugs
•  Notable Approval: FDA Approves First At-home Starting Dose for Alzheimer’s Disease Treatment
• Final Guidance: Formal Meetings Between the Food and Drug Administration and Sponsors or Requestors of Over-the-Counter Monograph Drugs
• Final Guidance: Topical Dermatologic Corticosteroids: In Vivo Bioequivalence
• Final Guidance: Psychedelic Drugs: Considerations for Clinical Investigations

July 10, 2026

• 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)
    • Appendix A: Product Name Index (updated)
    • Appendix B: Product Name Sorted by Applicant (updated)
    • Appendix C: Uniform Terms (updated)
  • Reference Listed Drugs by ANDA Reference Standard List (updated)
  • Orange Book Patent Listing Dispute List (updated)
• FDA approves pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph each with enfortumab vedotin-ejfv for muscle invasive bladder cancer
• FDA approves isatuximab-irfc for subcutaneous injection for multiple myeloma indications

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.