News Related to FluoGuide A/S

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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.