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BioWorld - Saturday, December 9, 2023

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Home » Topics » Regions
  • Vuno 25oct23
    Oct. 25, 2023
    By Marian (YoonJee) Chu

    FDA clears Vuno’s AI-based MRI reading software for early Alzheimer’s detection

    Vuno Inc. gained a U.S. FDA’s 510(k) clearance for its artificial intelligence (AI)-powered brain quantification device, Vuno Med-Deepbrain, to diagnose possible dementia in patients “even before mild cognitive impairment.”
  • Stem cells
    Dec. 24, 2019
    By Elise Mak

    China approves two more CAR T trials; Legend’s candidate gets FDA breakthrough status

    BEIJING – China made strides in the CAR T space this month. The country approved two more candidates to enter clinical trials in December, and forerunner Nanjing Legend Biotech Co. Ltd. said its investigational CAR T therapy LCAR-B38M/JNJ-4528 co-developed with Janssen Biotech Inc. won FDA’s breakthrough therapy designation.
  • Dec. 20, 2019
    By Elise Mak

    China approves two more CAR T trials; Legend’s candidate gets FDA breakthrough status

    BEIJING – China made strides in the CAR T space this month. The country approved two more candidates to enter clinical trials in December, and forerunner Nanjing Legend Biotech Co. Ltd. said its investigational CAR T therapy LCAR-B38M/JNJ-4528 co-developed with Janssen Biotech Inc. won FDA’s breakthrough therapy designation.
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