uniQure N.V. is seeking FDA approval for a gene therapy targeting Huntington's disease amid leadership changes impacting the review process.
2 reports, 1 independent
Updated Sep 2
Gone quiet
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What happened
uniQure N.V. is seeking FDA approval for a gene therapy targeting Huntington's disease amid leadership changes impacting the review process.
Who's involved
What this event is mainly aboutKeep exploring
The entities involved
- FDA
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Marty Makary
American surgeon and FDA Commissioner
Nothing else this week.
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Vinay Prasad
US hematologist–oncologist
Nothing else this week.
Related events
- The FDA reversed its decision regarding a gene therapy application from uniQure N.V.
- A network focused on cell and gene therapies is expanding to include sites in Northern California, involving the CA Institute for Regenerative Medicine and the FDA.
- FDA approval is the goal for product candidates from Daré Bioscience, Inc.