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  • UniQure to file gene therapy for approval, reflecting major shifts at FDA
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UniQure to file gene therapy for approval, reflecting major shifts at FDA

BioPharma Dive

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.

Rare Disease

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pharminent June 17, 2026 (Last updated: June 19, 2026)

BioPharma Dive

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.

Rare Disease

Read full story

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