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Rare Disease Therapeutics
Biotech
In another reversal, FDA to reconsider Regenxbio gene therapy
The agency has reversed its previous demand that Regenxbio use an untreated control arm for the one-time Hunter syndrome candidate.
Angus Liu
Jun 22, 2026 10:26am
Kyverna begins rolling FDA submission for autoimmune CAR-T in SPS
May 12, 2026 4:27pm
Fierce Pharma
FDA to reconsider rejected cell therapy. Could uniQure be next?
May 7, 2026 10:40am
Small pools, big ideas: Rare disease community reimagines trials
Apr 17, 2026 3:00am
Fierce Pharma
FDA snubs Ultragenyx gene therapy over manufacturing issues
Jul 14, 2025 10:16am
