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Sat, Jul 05, 2025

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Home » Topics » Regulatory
  • Antibody drug conjugates adcs 3d
    July 4, 2025

    Innocare’s ICP-B794 gains IND clearance in China

    Innocare Pharma Ltd. has obtained IND approval from China’s National Medical Products Administration (NMPA) to initiate a clinical trial of the B7-H3 targeted antibody-drug conjugate.
  • Multiple myeloma illustration
    July 4, 2025

    Brightpath’s BP-2202 designated orphan drug for multiple myeloma

    Brightpath Biotherapeutics Co. Ltd.’s iPS cell-derived BCMA CAR-natural killer T cell therapy candidate has been awarded orphan drug designation by the FDA for the treatment of multiple myeloma.
  • July 3, 2025

    Kennedy adopts two ACIP vaccine recommendations

    With no U.S. CDC director in place yet, Health and Human Services Secretary Robert Kennedy recently adopted two vaccine recommendations from the April meeting of the Advisory Committee for Immunization Practices (ACIP), making them official CDC recommendations and ensuring coverage of the vaccines for the specified populations.
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    By Mari Serebrov

    Will biosimilar carve-outs put R&D for older MAbs on ice?

  • Feb. 27, 2013
    By Mari Serebrov

    Omontys Recall Rings Alarm Over Biosimilars

  • Jan. 29, 2013
    By Mari Serebrov

    Don’t Call Them Generics!

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