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Second death in Novartis gene therapy trials under investigation
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Second death in Novartis gene therapy trials under investigation
Novartis has filed for U.S. Food and Drug Administration approval of the gene therapy, Zolgensma, and a decision is expected within weeks. The FDA submission was based on findings from a trial of 15 babies treated with Zolgensma. One patient died from respiratory failure, which was deemed by the investigator and an independent monitor to be unrelated to the gene therapy.
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