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- FDA lifts opposition to Huntington’s disease gene therapy, clearing path for developmentThe Readout Loud podcast this week highlighted a regulatory shift for a gene therapy aimed at Huntington’s disease. The Food and Drug Administration reversed its earlier opposition, removing a key…
- UniQure plans to file Huntington’s disease gene therapy with FDA after leadership shift eases data requirementsUniQure, a Dutch biotech, announced it will seek FDA approval for its gene therapy targeting Huntington’s disease later this summer. The company said FDA staff indicated that three years of data f…