AUG 21, 2026 · REGULATORY LABEL UPDATE
FDA supplemental approval: Benlysta (Labeling)
U.S. Food and Drug Administration
FDA supplemental approval for labeling change to belimumab; regulatory action affecting product information but does not report clinical trial efficacy data.
Reported
Approval date2026-08-21
Application numberBLA761043
Formulation strength200 mg/mL