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BioWorld - Wednesday, March 18, 2026

EMA

Home » Topics » Regulatory » EMA
  • Cervical cancer cervix
    March 12, 2026

    Cbio’s novoleucel cleared for clinic for cervical cancer

    Cbio A/S has received European regulatory clearance to begin a first-in-human trial of novoleucel, the company’s next-generation T-cell therapy, in late-stage cervical cancer. The phase I/IIa study will enroll patients with persistent or recurrent cervical cancer at Karolinska University Hospital.
  • Feb. 27, 2026
    By Jennifer Boggs

    Moderna’s combo flu/COVID vaccine gets thumbs up in EU

    The EMA’s Committee for Medicinal Products for Human Use recommended approval of Moderna Inc.’s Mcombriax (mRNA-1083), positioning it to potentially become the world’s first combination vaccine for both seasonal influenza and COVID-19.
  • Heart cross section valves
    Feb. 19, 2026

    Affinia’s AFTX-201 designated EU orphan drug

    Affinia Therapeutics Inc.’s AFTX-201 has been awarded orphan drug designation by the EMA for BAG3-associated dilated cardiomyopathy.
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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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  • Lynn Yoffee
  • Nuala Moran
  • Cormac Sheridan
  • Marie Powers
  • Randy Osborne
  • Mari Serebrov
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