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Tue, May 20, 2025

Regulatory

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Home » Topics » Regulatory
  • Koreabio humanase koh sungho 9may25
    May 19, 2025
    By Marian (YoonJee) Chu

    FDA shift from animal testing fuels organoid, organ-on-chip demand

    The U.S. FDA’s decision to phase out animal testing for INDs is driving a new market of alternative, nonanimal testing technologies like organoids and organs-on-a-chip, speakers at Bio Korea 2025 said.
  • Neurons with dendrites affected by amyloid plaques in alzheimers disease
    May 19, 2025
    By Annette Boyle

    Fujirebio Alzheimer’s test wins first FDA clearance

    Fujirebio Diagnostics Inc.’s Alzheimer’s disease assay received the U.S. FDA’s first clearance for a blood test for the debilitating neurodegenerative disease. Fujirebio’s Lumipulse G pTau217/ß-Amyloid 1-42 plasma ratio is indicated for the early detection of amyloid plaques associated with Alzheimer’s disease in symptomatic individuals aged 55 years and older.
  • May 19, 2025
    By Mari Serebrov

    Street a bit uneasy ahead of Urogen adcom

    With a PDUFA date less than four weeks away, Urogen Pharma Inc. has been having a rough ride on the Street since the U.S. FDA released a joint briefing document for the May 21 Oncologic Drugs Advisory Committee meeting on UGN-102 (mitomycin).
Read More

Blog Posts

  • Aug. 11, 2016
    By Mari Serebrov

    Will biosimilar carve-outs put R&D for older MAbs on ice?

  • Feb. 27, 2013
    By Mari Serebrov

    Omontys Recall Rings Alarm Over Biosimilars

  • Jan. 29, 2013
    By Mari Serebrov

    Don’t Call Them Generics!

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