Author: Govzilla

Govzilla’s Top 20 Posts of All Time

To serve as a resource for you and your company and to help orient you to the scope of the Govzilla blog, we assembled a list of some of our most useful, relevant, and popular articles of all time.

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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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