Gradalis Secures FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for Vigil® (Gemogenovatucel-T): An ...
Recognizing clinical evidence from the Phase 2b VITAL Study of Vigil in homologous recombination proficient (HRP) patients with high clonal tumor mutation burden (cTMB-H) RMAT designation provides multiple benefits including increased FDA interactions and …