JUL 23, 2026 · REGULATORY LABEL UPDATE
FDA supplemental approval: Tyruko (REMS)
U.S. Food and Drug Administration
FDA supplemental approval action for a REMS (Risk Evaluation and Mitigation Strategy) regulatory requirement; does not contain clinical trial data or efficacy evidence.
Reported
Approval date2026-07-23
BLA application numberBLA761322
Product concentration20 mg/mL