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Drug Approval Process

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FDA Agrees Three‑Year Phase I/II Data Can Support uniQure’s AMT‑130 Accelerated BLA

It opens a route for accelerated approval with negotiations underway over the design of a required post‑approval confirmatory trial.

Personalized mRNA Vaccine Shows Durable Survival Signal in Early Pancreatic Cancer

Roivant’s Brepocitinib Succeeds in 52-Week Dermatomyositis Phase 3 as Companies Target 2026 FDA Filing