FDA Investigates Tumour Risk Linked to Novartis Gene Therapy
The FDA said it is investigating a risk of neoplasia associated with Novartis’ Zolgensma gene therapy. Novartis disclosed two cases involving tumours in children.
The US Food and Drug Administration said on Friday it was investigating a risk of neoplasia, or tumour formation including malignancy, associated with Novartis' BX:NOT gene therapy Zolgensma.The Swiss drugmaker earlier in the day disclosed two cases in which tumours in children showed evidence of b…