The U.S. Food and Drug Administration said on Tuesday that some data from early ...
NEW YORK - The U.S. Food and Drug Administration said on Tuesday that some data from early testing of Novartis’ more than $2 million gene therapy Zolgensma was manipulated, but the agency believes the treatment should remain on the market.
The regulator plans to take action against the company including possible civil or criminal penalties. “The data in question were a small portion of our overall submission and are limited to an older process no longer in use.” The FDA said its concerns were currently limited to a small portion of product testing data included in the marketing application for the therapy.
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