Onco-Summaries: Daily Oncology Updates at a Glance

18/03/2026

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• Idience's venadaparib received the FDA fast track designation for gastric cancer

• FluoGuide's FG001 imaging agent received the FDA fast track designation for glioma

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Idience's venadaparib received the FDA fast track designation for gastric cancer (Ref)

The US FDA granted the fast track designation to Idience's venadaparib (PARP inhibitor) for the treatment of gastric cancer.

• Lee Won-sik, CEO, Idience: “This Fast Track designation is highly meaningful in that the FDA has recognized Venadaparib’s clinical potential and its ability to help address unmet medical needs. We will do our utmost to accelerate our global clinical development and deliver a new treatment option.”

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FluoGuide's FG001 imaging agent received the FDA fast track designation for glioma (Ref)

The US FDA granted the fast track designation to FluoGuide's FG001 as an intraoperative imaging agent to guide surgical resection of high-grade glioma.

• Donna Haire, COO, FluoGuide: “Fast Track designation for FG001 is a meaningful recognition by FDA of the significant unmet need in high-grade glioma and the potential of our program to improve intraoperative tumor detection. We greatly value the opportunity to work closely with the FDA and deeply appreciate their engagement as we continue to advance FG001 for patients facing this devastating cancer.”

• FluoGuide is in preparation to initiate the US Phase 2 registration trial of FG001 in high-grade glioma with first patient planned to be enrolled in Q2'26

  
  

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