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FDA raises accuracy questions over trial data of gene therapy drug

External Link - Source: NBC News

More than two months after the Food and Drug Administration approved an expensive new gene therapy drug for a rare disease in children, the agency said it has major questions about the accuracy of some of the testing data. The FDA said Tuesday that the drug maker — AveXis, which is owned by Novartis — was aware of problems with the data and didn’t inform the agency until after the drug was approved.

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