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- UniQure files FDA priority review request for Huntington’s gene therapy AMT-130UniQure, a Dutch biotech, announced on Wednesday that it has submitted applications to the U.S. Food and Drug Administration seeking a priority review for its gene therapy AMT-130, which targets th…
- FDA vows tighter review of foreign clinical trial data amid rising Chinese influenceTop FDA officials announced that the agency will intensify its oversight of clinical trial data generated outside the United States. The move is aimed at ensuring that foreign data meet the same st…