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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.
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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.
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benzinga.com
FDA Signals uniQure Huntington Gene Therapy Data Could Back Accelerated Approval - uniQure (NASDAQ:QURE)
uniQure stock surged after the FDA said three-year AMT-130 data could support accelerated approval for Huntington's disease treatment.
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arstechnica.com
"Truly evil" FDA rejection of gene therapy overturned after Trump official ousted
Gene therapy company UniQure had another FDA meeting after Vinay Prasad's exit.
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cnbc.com
UniQure to seek FDA approval for Huntington's disease gene therapy after previous clash with agency
The announcement comes months after UniQure became embroiled in a public debate with FDA leaders over the clinical trial data supporting its application.