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- FDA places uniQure’s Huntington’s gene therapy in priority review, targeting May 2027 approvalThe U.S. Food and Drug Administration has accepted uniQure’s filing for its Huntington’s disease gene therapy and placed the product under priority review, a step that could accelerate a decision b…
- FDA sets May 1 decision date for uniQure's Huntington's disease gene therapy after year-long regulatory sagaThe U.S. Food and Drug Administration has accepted uniQure's biologics license application for its Huntington's disease gene therapy and placed it on the priority review track, with a May 1 target…BioSpace · 7d agoRegulatoryPositive