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Novartis Gene Therapies controversies

Controversies tied to this brand in public sources. A listing is not a finding of fault.

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  1. 2019

    Regulatory data-manipulation controversy

    The US Food and Drug Administration accused AveXis of data manipulation in a regulatory submission and other submissions after Zolgensma's approval. An investigation alleged that Brian Kaspar and Allan Kaspar ordered and attempted to conceal the manipulation. Both were subsequently removed from the company.