Novartis acknowledged seven previously unknown reports of tumors in children treated with its spinal muscular atrophy gene therapy Zolgensma, a development driven by new disclosures from an advocacy group and social media posts. Novartis said it has received nine total tumor reports since approval in 2019, with two cases showing evidence consistent with a causal link and the remainder under ongoing assessment. The company reiterated that the theoretical risk of tumorigenicity from the adeno-associated virus (AAV) vector is already included in the prescribing information. Still, regulators are drawing attention to the case details as families push for transparency and additional follow-up, according to the reporting. The episode underscores how post-approval pharmacovigilance remains central for long-duration gene therapies, where latency and evolving attribution complicate safety evaluation. It also raises pressure on long-term registries and imaging/biopsy documentation for patients and clinicians. For the biotech sector, the update is a reminder that even in therapies with strong efficacy and broad uptake, investor and clinical trust can be heavily influenced by how quickly sponsors communicate emerging signals and how regulators decide whether additional studies are needed.