FDA Fast Track Designation For BST02 In Treatment Of Liver Cancer
“BST02 has received approval from the FDA for Phase I/II clinical trial in October 2023 and has also been approved by the Center for Drug Evaluation (CDE) of the China National Drug Administration in January, 2024. This marks the first TIL cell therapy drug for liver cancer to progress to the clinical stage globally. Furthermore, another product from Biosyngen, BRG01, was granted fast track designation in July 2023.”
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