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BioWorld - Thursday, July 2, 2026

CHMP

Home » Topics » Regulatory » CHMP
  • Eu flags at ec building
    June 29, 2026
    By Nuala Moran

    EMA reverses its stance on Acadia’s Rett syndrome therapy Daybu

    Following an initial rebuff in February 2026, the EMA’s Committee for Medicinal Products for Human Use (CHMP) is recommending approval of Acadia Pharmaceuticals Inc.’s Daybu (trofinetide) for treating neurobehavioral symptoms of Rett syndrome, after it took another look at the file.
  • Tavneos
    June 26, 2026
    By Nuala Moran

    EMA to pull Amgen’s Tavneos over ‘incorrect and misleading’ data

    The EMA is recommending withdrawing Amgen Inc.’s complement inhibitor Tavneos (avacopan) from the market in Europe, saying data provided at the time it assessed the MAA “were found to be incorrect and misleading and could no longer be relied upon for demonstrating Tavneos’ effectiveness.”
  • Floating antibody drug conjugates
    May 28, 2026
    By Marian (YoonJee) Chu

    TROP2 ADCs progress into first-line for lung, breast cancers

    Multiple updates on TROP2-directed antibody-drug conjugates (ADCs) for lung and breast cancers highlight both progress made and opportunities for improvement for the targeted class of cancer therapeutics.
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