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BioWorld - Friday, May 29, 2026

EMA

Home » Topics » Regulatory » EMA
  • 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.
  • Map of europe medicine
    May 27, 2026
    By Nuala Moran

    Initial data hint that US MFN pricing is hitting access in Europe

    There are initial signs that President Donald Trump’s most-favored nation (MFN) policy may be further delaying access to new drugs in Europe, as companies hold off commercializing in these countries to avoid lower European prices being referenced in the U.S.
  • Jascayd
    May 22, 2026
    By Nuala Moran

    EMA poised to be 4th regulator approving Boehringer’s Jascayd lung drug

    As generic versions of its blockbuster drug Ofev (nintedanib) start to hit the market, Boehringer Ingelheim GmbH looks to have swerved the patent cliff, with European and Japanese regulators both approving a potential replacement, Jascayd (nerandomilast), this week. At its monthly meeting, the EMA’s Committee for Medicinal Products for Human Use also recommended Novartis AG’s Vijoice (alpelisib) be given conditional approval in the treatment of PIK3CA-related overgrowth spectrum disorders.
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Blog Posts

  • Oct. 28, 2013
    By Marie Powers

    Patient Experience Still Undervalued in Regulating Drugs

  • July 10, 2012
    By Cormac Sheridan

    Venter, Watson Warm Up for Clash of the Titans

  • May 7, 2012
    By Nuala Moran

    The EMA’s Shambolic Handling of Glybera

  • June 27, 2011
    By Lynn Yoffee

    Video Coverage from #BIO2011 - State of the British Biotech Industry

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