The Food and Drug Administration is taking action against pharmaceutical giant Novartis for failing to report faulty data to government regulators about its $2.1 million drug that treats a paralyzing, fatal genetic disease.

The FDA plans to “use its full authorities to take action, if appropriate, which may include civil or criminal penalties” against the company’s gene therapy subsidiary, AveXis Inc., FDA Commissioner Ned Sharpless said in a statement Tuesday.

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