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UniQure to file gene therapy for approval, reflecting major shifts at FDA
The decision marks another regulatory U-turn following the exits of Marty Makary and Vinay Prasad, suggesting to some analysts that current FDA leadership may be more flexible in certain cases.
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biopharmadive.com
UniQure to file gene therapy for approval, reflecting major shifts at FDA
The decision marks another regulatory U-turn following the exits of Marty Makary and Vinay Prasad, suggesting to some analysts that current FDA leadership may be more flexible in…
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statnews.com
Following dispute with FDA, UniQure is cleared to submit Huntington’s treatment for approval
The FDA has reversed its opposition to a closely watched experimental treatment for Huntington’s disease, clearing a path for its maker.
