Tag: novartis

FDA Investigating Serious Risk of Malignancy Linked to Zolgensma Gene Therapy

6 Nov 2026 9:02 p.m. · Source: US Food and Drug Administration

FDA says postmarketing reports link Zolgensma to malignancies, including confirmed insertional oncogenesis involving the GLI1 gene, and warns the risk applies to Itvisma as well.

Health Science & Technology Politics and Government Medical Science Federal Government Legal Zolgensma Itvisma Food and Drug Administration insertional oncogenesis spinal muscular atrophy gene therapy Novartis Food Recalls FDA Drugs