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US FDA probes tumor risk in Novartis gene therapy Zolgensma

By PulseAugur Editorial · [1 sources] ·

The U.S. Food and Drug Administration (FDA) is investigating potential tumor risks associated with Novartis' gene therapy, Zolgensma. This investigation follows reports of neoplasia, including malignancy, in children treated with the therapy. While the FDA currently believes the benefits of Zolgensma outweigh the risks, the agency is considering further action after nine cases of tumors emerged among approximately 6,000 treated infants. AI

RANK_REASON Regulatory investigation into a drug's safety profile. [lever_c_demoted from significant: ic=1 ai=0.0]

Read on SCMP — Tech →

AI-generated summary · Google Gemini · from 1 sources. How we write summaries →

US FDA probes tumor risk in Novartis gene therapy Zolgensma

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Regulatory investigation into a drug's safety profile. [lever_c_demoted from significant: ic=1 ai=0.0]
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COVERAGE [1]

  1. SCMP — Tech TIER_1 English(EN) · Reuters ·

    US regulator investigates tumour risk in children given Novartis gene therapy

    The US ⁠Food and Drug Administration said ⁠on Friday it was investigating a ⁠risk of neoplasia, or tumour formation including malignancy, associated with Novartis’ gene therapy Zolgensma. The Swiss drug maker earlier in the day disclosed two cases in which tumours in children sho…

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