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BioWorld - Tuesday, December 9, 2025

EMA

Home » Topics » Regulatory » EMA
  • Dec. 5, 2025

    Avencell’s AVC-203 cleared for clinic for B-cell malignancies

    Avencell Therapeutics Inc. has received clinical trial clearances from the FDA and EMA to conduct a phase I/II trial (Quadvance) of AVC-203 for the treatment of relapsed or refractory B-cell malignancies.
  • Farapoint 1dec25
    Dec. 1, 2025
    By Annette Boyle

    Boston Sci's Farapoint secures CE mark

    Proving its latest addition to the Farapulse pulsed field ablation (PFA) platform is no turkey, Boston Scientific Corp.'s Farapoint PFA catheter received CE mark as the U.S. celebrated Thanksgiving. Farapoint is indicated for ablation of the cavotricuspid isthmus, specifically to treat right atrial flutter.
  • Plasma bags
    Nov. 28, 2025

    Kedrion’s aceruloplasminemia treatment designated EU orphan drug

    Kedrion SpA’s investigational plasma-derived treatment for congenital aceruloplasminemia has been awarded European orphan drug designation by the EMA. The company is working to advance this treatment toward clinical development in Europe.
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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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