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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“The designation reinforces the significant unmet need for effective treatment options for patients with advanced breast cancer,” said Charles Baum, M.D., Ph.D., Chief Executive Officer of Terremoto Biosciences. “We are committed to advancing highly selective therapies designed to expand treatment options for patients with difficult to treat cancers.”
“Up to five U.S. clinical sites are planned for THIO-101 Parts C and D this year, and we expect to activate a second U.S. site in the coming weeks,” said Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA. “To date, data has shown overall survival (OS) beyond two
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