FDA investigating tumor risks linked to Zolgensma, reviewing safety data and long-term follow-up studies

The FDA is investigating tumor risks linked to Novartis' gene therapy Zolgensma, used to treat spinal muscular atrophy. Novartis confirmed it is aware of nine tumor cases in treated patients, and the FDA is reviewing safety data, prescribing information and long-term follow-up studies to determine if further regulatory action is required.

Detected & updated continuously · Source: Nebula