FDA placed a clinical hold on a gene therapy involving Hunter.

The entities involved

• Hunter →
  • Hunter, a DPS board member, holds a dual role as a union employee while CEA represents DPS educators.Sun 12:52
• FDA →
  • Generic medicine services are seeking approval for launch from the FDA.Mon 17:49
  • A company is seeking FDA feedback on its NEO212 program, with a meeting scheduled at the FDA's White Oak campus.Mon 14:56

Related events

• Solid Biosciences received FDA approval for a gene therapy trial on July 9, 2025.Jun 8
• The FDA reviewed gene therapy applications and provided milestone payments for dosing involving Regenxbio and AbbVie.Aug 6
• uniQure N.V. traded on the Nasdaq stock exchange and submitted a Biologics License Application (BLA) for accelerated approval of its gene therapy.Sep 9
• The FDA reviewed the Biologics License Application (BLA) for MOGENRY, a gene therapy, involving Nanoscope Therapeutics, Inc.Sep 9
• The FDA approved various advanced therapies, including oral medication from Roche, a gene-targeting drug from Biogen, and a one-time gene therapy from Novartis.Sep 14