Novartis begins Zolgensma study after FDA’s hold lifts

Aiming to expand the use of Zolgensma, Novartis has announced the launch of a new phase three study following the FDA’s decision to remove restrictions and partial clinical trial hold. Novartis plans to evaluate the use of Zolgensma to treat patients (aged 2-18) for spinal muscular atrophy. The FDA’s 2019 hold blocked efforts to treat older patients with Zolgensma after safety concerns were raised. The pause was lifted following Novartis’ FDA submission of more data.

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