Pharma giant admits data manipulation in FDA application for multi-million-dollar gene therapy

A newly published statement from the US Food & Drug Administration (FDA) has revealed inaccurate, intentionally manipulated data was included as part of a submission for a major new gene therapy that was approved for public use in May. The FDA alleges AveXis, the company developing the drug, was aware of the data manipulation issue prior to FDA approval but did not notify the regulatory agency until after the product was approved.

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Category: Medical

Tags:

• Data
• FDA
• gene therapy
• Genetics

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