Nuvation Bio gets FDA Fast Track for safusidenib in glioma
Nuvation Bio says the FDA granted Fast Track designation for safusidenib in IDH1-mutant glioma, with pivotal Phase 3 Sigma study enrollment underway.
NUVB - earlier PR: Nuvation Bio Granted FDA Fast Track Designation for Safusidenib for Treatment of IDH1-Mutant Glioma -Designation offers pathway to expedite regulatory review, pending positive data, and reinforces safusidenib's potential to address significant Medical needs for patients with IDH1-mutant glioma -Pivotal Phase 3 Sigma study enrollment underway