Category: FDAzilla

AveXis

AveXis’s New Gene Therapy Approved but New Questions Are Raised

FDA issued a particularly harsh press release on August 6, 2019 addressing the data accuracy issues with the BLA for the gene therapy product, Zolgensma, which was approved by FDA on May 24, 2019. It seems the FDA is using them, and more importantly their parent company Novartis, as an example of what not to do.

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