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US FDA Investigates Tumor Risk in Children Treated with Novartis Gene Therapy

  • The US FDA is investigating a risk of neoplasia associated with Novartis' gene therapy Zolgensma.
  • Novartis disclosed two cases where tumors in children showed evidence of being linked to Zolgensma.
  • Nine reports of tumors in children treated with Zolgensma for spinal muscular atrophy have been acknowledged by Novartis.
  • The cases involve children less than two years old treated for spinal muscular atrophy.
  • The FDA's investigation is ongoing, and further updates are expected.

Timeline

  1. Novartis reports possible tumor link to SMA gene therapy

    Novartis acknowledges seven previously unknown instances of tumors in children treated with its SMA gene therapy.

  2. FDA probes Novartis gene therapy tumor risk

    The FDA is investigating a risk of tumor formation associated with Novartis' gene therapy Zolgensma.

  3. Latest

    Nine tumor reports in Novartis gene therapy patients

    Novartis confirms nine reports of tumors in children treated with its gene therapy Zolgensma for SMA.

Articles (5)

US FDA Investigates Tumor Risk in Children Treated with Novartis Gene Therapy | Split Angle