Novartis acknowledged seven newly reported tumor cases in children after treatment with its spinal muscular atrophy gene therapy Zolgensma, and said nine total tumor reports have been received since approval. The company stated that two cases show evidence suggesting a possible link to the therapy, while the remaining reports have not been causally attributed. The disclosure followed advocacy pressure and communications to neurologists, with groups calling for regulatory review of potential vector-related tumorigenicity. The company noted that theoretical tumor risk from AAV vector integration is included in prescribing information. The update renews attention on long-term post-marketing surveillance and the evidentiary bar needed to establish causality for late-emerging events in AAV-based therapies.