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U.S. FDA
Biotech
FDA demands ph. 3 trial of uniQure's Huntington's gene therapy
Although uniQure plans to discuss phase 3 designs with the FDA, it argues that a sham-controlled study as the agency requested isn't possible.
Angus Liu
Mar 2, 2026 10:45am
FDA to ‘carefully shepherd’ CAR-T for autoimmune disease: Prasad
Feb 3, 2026 11:40am
Fierce Pharma
3 biopharma CEOs explain why they are 'authentically optimistic'
Jan 6, 2026 11:54am
FDA unveils new pathway to speed custom gene editing therapies
Nov 12, 2025 5:00pm
Fierce Pharma
George Tidmarsh exits as LinkedIn post sparks lawsuit, probe
Nov 3, 2025 11:13am
uniQure's gene therapy for Huntington's hits FDA roadblock
Nov 3, 2025 10:03am
