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Gene Therapy Manufacturing Regulation

Novartis' Zolgensma Had Manipulated Data In Application, US FDA Says

  • Analysis

Executive Summary

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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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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