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Cell & Gene Therapy

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Biotech

Senior FDA official fires back at uniQure amid controversy

A senior FDA official said the agency never agreed with uniQure's plan, saying “the FDA will always say, ‘Well, we have to see the data when we get it.’”
Angus Liu , Darren Incorvaia Mar 5, 2026 3:33pm
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UniQure, FDA back-and-forth intensifies

Mar 5, 2026 11:55am
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Bayer ditches 1 AAV gene therapy from Pompe disease pair

Mar 4, 2026 9:59am
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FDA details Regenxbio rare disease rejection

Mar 3, 2026 12:56pm
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FDA fully releases clinical hold on Intellia CRISPR trials

Mar 2, 2026 10:55am
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FDA demands ph. 3 trial of uniQure's Huntington's gene therapy

Mar 2, 2026 10:45am