20/08/2026 US FDA Grants Fast Track Designation to Safusidenib for IDH1‑Mutant Glioma US FDA Grants Fast Track Designation to Safusidenib for IDH1‑Mutant Glioma (Ref) Nuvation Bio announced that the US FDA has granted Fast Track Designation to safusidenib (IDH1 inhibitor) for the treatment of IDH1‑mutant glioma. This designation enables expedited regulatory review and closer FDA engagement Phase 2 J201 trial showed a confirmed objective response rate of 51.9%, with durable re