Novartis secured FDA approval for an expanded formulation of its one‑time gene therapy Itvisma aimed at older patients with spinal muscular atrophy (SMA). The approval extends the eligible patient population beyond the youngest cohorts typically treated with gene therapy and could broaden clinical use and commercial reach. Novartis will position the label change to capture patients who were previously ineligible for single‑dose gene replacement strategies. The decision may influence clinical practice and payer discussions given the long‑term cost and access implications of expanding a one‑time therapy to older age groups.