Following dispute with FDA, UniQure is cleared to submit Huntington’s treatment for approval
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UniQure is cleared to submit its Huntington's treatment for approval following a dispute with the FDA. The company plans to seek FDA approval for its gene therapy, although there were previous disagreements between UniQure and the agency. The outcome of the submission is uncertain, with some reports indicating a potential accelerated approval pathway and others highlighting ongoing controversy over the regulatory decision.
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