FG001

Drug

Related News

FDA Approves Nivolumab for Pediatric Hodgkin Lymphoma, Clears Two Investigational Drugs for Trials

Apr 03, 2026

The FDA has approved nivolumab with chemotherapy for pediatric and adult Hodgkin lymphoma patients aged 12+, based on clinical trial data showing improved survival. Separately, the agency cleared investigational new drug applications for FG001 for brain cancer surgery visualization and FRF-001 gene therapy for FOXG1 syndrome, allowing both to proceed to clinical trials.

FluoGuide Receives FDA Fast Track Designation for FG001 in High-Grade Glioma

Mar 19, 2026

The U.S. FDA has granted Fast Track designation to FluoGuide's FG001 as an intraoperative imaging agent for high-grade glioma surgical resection. The designation follows IND clearance in January and enables accelerated development and regulatory review.

FDA Clears FluoGuide's IND Application for FG001 in High-Grade Glioma

Feb 21, 2026

The U.S. Food and Drug Administration has cleared FluoGuide's Investigational New Drug application for FG001, enabling the company to proceed with a Phase 2 registration trial in high-grade glioma patients with first enrollment expected in Q2 2026.