Issue №126 · 2026-09-19

Daily Briefing · Issue №126 · 2026-09-19

Physicians

FDA approves Ultragenyx’s gene therapy Fayuvi for rare neurodegenerative disorder

  • Ultragenyx scored a belated regulatory win with FDA approval for a first-in-disease gene therapy, giving the company a boost after a previous regulatory rejection and a recent late-stage setback.
Fierce Pharma ↗
Digital Health

Clinical trials reach a new automation inflection point

  • As trial complexity grows, agentic AI is emerging as a new model for connecting workflows and accelerating execution.
Fierce Pharma ↗
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