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15 days ago
FDA panel to focus on safety of Novartis gene therapy drug
July 10, 2017 / 12:36 PM / 15 days ago

FDA panel to focus on safety of Novartis gene therapy drug

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July 10 (Reuters) - The U.S. Food and Drug Administration will ask a panel of advisors to focus on the safety of Novartis AG's experimental gene therapy drug when it meets to review the leukemia treatment on Wednesday.

The keenly anticipated preliminary review by the U.S. Food and Drug Administration, posted on its website on Monday, comes two days ahead of the advisory panel meeting, which will discuss the drug and vote on whether the benefits exceed the risks.

If approved, the drug would be first gene therapy to be approved in the United States. The FDA is not obliged to follow the recommendations of its advisors but typically does so. (Reporting by Toni Clarke in Washington; Editing by Nick Zieminski)

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