Novartis' Zolgensma Had Manipulated Data In Application, US FDA Says
Gene therapy should remain on the market, FDA says, but Novartis could face civil or criminal penalties. Firm knew of problems before approval.
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OTAT Director Bryan, who has worked at the FDA for more than 20 years, will depart by the end of March as the agency’s cell and gene therapy operations are poised for a major overhaul and a large number of new hires.
Officials from the US Food and Drug Administration cited their reasons for refusing to review new applications for companies with unresolved data integrity failures.
Novartis has completed its absorption of AveXis and rebranded the acquired gene therapy specialist that developed the soon-to-be SMA blockbuster Zolgensma despite struggling to meet the data integrity standards of regulators and big pharma.