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"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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arstechnica.comStai leggendo16 h fa

"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.

originale

biopharmadive.com1 g fa

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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cnbc.com15 h fa

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.

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statnews.com19 h fa

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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Timeline cronologica

mercoledì 17 giugno 2026·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…
mercoledì 17 giugno 2026·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.
mercoledì 17 giugno 2026·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.
mercoledì 17 giugno 2026·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.