FDA Sets May 1 PDUFA Action Date for uniQure’s Huntington’s Disease Gene Therapy

Coverage, in order

1. 9d ago
   first GEN Genetic Engineering News indie

   FDA Sets May 1 PDUFA Action Date for uniQure’s Huntington’s Disease Gene Therapy

   The FDA has set a May 1 target action date under the Prescription Drug User Fee Act (PDUFA) for uniQure’s Huntington’s disease gene therapy candidate ifezuntirgene inilparvovec—which, if approved, would be the first treatment shown to modify the fatal, inherited neurodegenerative disorder—after…

2. 8d ago
   Pharmaphorum UK indie

   uniQure set for May FDA verdict on Huntington's gene therapy

   uniQure set for May FDA verdict on Huntington's gene therapy Phil.Taylor Tue, 03/11/2026 - 09:59

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