FDA probes tumour risk linked to Novartis Zolgensma
In short
The US FDA is looking into a possible tumour risk linked to Novartis’ Zolgensma gene therapy after tumour cases were disclosed in children.
The investigation adds fresh scrutiny to the one-time treatment and could affect how the medicine is viewed by doctors, patients and investors.
What the reporting says
The FDA is investigating a tumour risk linked to Novartis’ Zolgensma gene therapy after disclosures of tumour cases in children. The fresh scrutiny follows those safety disclosures and puts the one-time treatment under closer review.
Why it matters
The FDA’s investigation follows disclosed tumour cases in children linked to Novartis’ Zolgensma, a one-time gene therapy. That creates fresh safety scrutiny for the drug and could weigh on confidence in the treatment among doctors, patients and investors.