Fintech regulation stories

Sep 2, 2026

UniQure seeks FDA approval for Huntington's gene therapy after reversal

Dutch biotech UniQure submitted its Huntington's disease gene therapy to the FDA for approval after the agency reversed its earlier position on the experimental treatment, following an unusually turbulent development process.

Sep 2, 20263 sources

Jul 28, 2026

FDA staff reiterate concerns about Replimune skin cancer treatment ahead of advisory meeting

FDA staff raised ongoing concerns about Replimune's experimental skin cancer therapy in briefing documents released before an advisory committee meeting, questioning the treatment's efficacy data.

Jul 28, 20261 source

Apr 22, 2026

Kyverna Therapeutics Plans FDA Submission for Stiff Person Syndrome Cell Therapy

Kyverna Therapeutics announced plans to submit its one-time CAR-T cell therapy for stiff person syndrome to the FDA after late-stage trial showed improvements in mobility and reduced disabilities in patients with the rare neurological disease.

Apr 22, 20261 source