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BioWorld - Tuesday, December 9, 2025

CHMP

Home » Topics » Regulatory » CHMP
  • Transparent capsule with dna and cells
    Nov. 14, 2025
    By Nuala Moran

    Charity bringing to EU market gene therapy spurned by pharma

    Fifteen years since the first patient was treated, and after being ditched by two companies, the EMA is recommending approval of Waskyra (etuvetidigene autotemcel), the first gene therapy for treating Wiskott-Aldrich syndrome.
  • Green checkmark and red x
    Oct. 17, 2025
    By Nuala Moran

    Mixed EMA news for Sanofi: Wayrilz yay, Rezurock nay

    There was a curate’s egg for Sanofi SA from this month’s meeting of the EMA’s Committee for Medicinal Products for Human Use, with a recommendation to approve one of the French pharma’s drugs – and the rejection of another.
  • Keytruda qlex3
    Sep. 23, 2025
    By Marian (YoonJee) Chu

    US FDA clears ‘one-minute’ Keytruda SC injection for solid tumors

    The U.S. FDA approved Merck & Co. Inc.’s Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) injection on Sept. 19, making it the first and only subcutaneously (SC)-administered immune checkpoint inhibitor that can be administered in about a minute.
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