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accelerated approval
Biotech
Regenxbio's Hunter gene therapy latest to face FDA delay
The review extension and request for more data bears the fingerprints of recently returned CBER head Vinay Prasad, M.D.
Darren Incorvaia
Aug 19, 2025 10:30am
Cash-strapped Sangamo seeks partner for new gene therapy
Jun 24, 2025 11:53am
Stealth CEO questions FDA rejection of rare disease drug
May 29, 2025 2:27pm
Regenxbio starts pivotal study for DMD gene therapy
Nov 18, 2024 2:24pm
Wave surfs DMD success to regulators' doors, sending stock up
Sep 24, 2024 9:51am
Ultragenyx gets green light to seek FDA approval of gene therapy
Jun 13, 2024 5:55am
