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Sun, Jun 01, 2025

CHMP

Home » Topics » Regulatory » CHMP
  • Antibody drug conjugate
    May 23, 2025
    By Nuala Moran

    Yanked from the market in 2022, GSK’s Blenrep gets an EU redo

    GSK plc’s Blenrep (belantamab mafodotin) is heading back to the market three years after being withdrawn, with the EMA’s Committee for Medicinal Products for Human Use recommending approval of the antibody-drug conjugate in combination therapy for the treatment of adults with relapsed or refractory multiple myeloma.
  • Vyvgart hytrulo
    April 28, 2025
    By Nuala Moran

    Argenx’s Vyvgart, Camurus’ Oczyesa among 16 recommended by CHMP

    Argenx NV is now well on the way to establishing a Vyvgart (efgartigimod alfa) franchise in severe autoimmune diseases, after getting the nod from the EMA in the treatment of progressive or relapsing chronic inflammatory demyelinating polyneuropathy.
  • Feb. 28, 2025
    By Nuala Moran

    Leqembi gets another thumbs-up amid CHMP February recommendations

    The EMA’s Committee for Medicinal products for Human Use (CHMP) is standing by its opinion on Leqembi (lecanemab) after the European .mission pushed back against a recommendation in November 2024 that the Alzheimer’s disease drug be approved
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