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Tue, May 13, 2025

CHMP

Home » Topics » Regulatory » CHMP
  • 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
  • Ema icons
    Jan. 31, 2025
    By Nuala Moran

    Leqembi review stalls again at European regulator

    EMA approval of the Alzheimer’s disease therapy Leqembi (lecanemab) has stalled once again, after the European Commission did not as usual nod through the agency’s recommendation, but told it to examine safety data that have recently become available.
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