July 14, 2026

• Public Notification: Xian Ling may be harmful due to hidden drug ingredients
• Public Notification: Detoxi Slim contains hidden drug ingredient (Updated)
• FDA approves gedatolisib with fulvestrant, with or without palbociclib, for HR-positive, HER2-negative locally advanced or metastatic breast cancer
• FDA grants traditional approval to selpercatinib for locally advanced or metastatic RET fusion-positive solid tumors

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

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.