The US FDA launched an investigation into Novartis’ spinal muscular atrophy gene therapy Zolgensma after reports of cancer in treated patients. The agency said it is examining a “serious risk” signal and the scope follows Novartis’ recent disclosure. For the gene-therapy sector, the step highlights how post-marketing safety signals can trigger rapid regulatory review even when therapies already carry established uptake. Manufacturers will likely face intensified pharmacovigilance scrutiny and potential updates to risk-management plans.