Novartis

JUL 16, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Fabhalta (Efficacy)

U.S. Food and Drug Administration

FDA supplemental approval for expanded indication or new efficacy claim; regulatory action without trial outcome data in this record.

JUL 15, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Tegretol (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval for labeling change to Tegretol (carbamazepine); does not contain clinical trial data or efficacy evidence.

JUL 1, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Kisqali (Efficacy)

U.S. Food and Drug Administration

FDA supplemental approval for efficacy expansion of ribociclib; regulatory action does not report trial outcomes and does not constitute clinical evidence of practice-changing benefit.

MAY 29, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Sandimmune (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval for labeling change to Sandimmune (cyclosporine); regulatory action does not report clinical trial outcomes or comparative efficacy.

MAR 26, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Tafinlar (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval for labeling changes to an established BRAF inhibitor; does not report clinical trial outcomes or efficacy data.