IND application to the US FDA for FG001 in patients with high-grade glioma (HGG)
“As we enter 2026, FluoGuide has reached a key inflection point. With the IND now submitted, we have further de-risked our lead program and established a well-defined regulatory path toward U.S. approval. Our mission remains unchanged: to maximizing outcomes in cancer surgery” said Morten Albrechtsen, CEO of FluoGuide and continue “We are now well positioned to advance toward registration”.
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“These data underscore gotistobart’s potential to redefine treatment for patients with hard-to-treat squamous NSCLC whose disease has progressed after initial therapy and who face limited options,” said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. “In second- and later lines of treatment, the clinical relevance of novel
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