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BioWorld - Tuesday, January 31, 2023

Orphan drug

Home » Topics » Regulatory » Orphan drug
  • Cancer cells1
    Jan. 26, 2023

    Tango's PRMT5 inhibitors receive IND clearance, orphan drug designation

    The FDA has cleared Tango Therapeutics Inc.'s IND application for TNG-462, a next-generation methylthioadenosine-cooperative (MTA) inhibitor of protein arginine methyl transferase 5 (PRMT5) for the treatment of cancers with methylthioadenosine phosphorylase (MTAP) deletion.
  • Jan. 9, 2023

    Lantern's LP-284 awarded US orphan drug designation for mantle cell lymphoma

    Lantern Pharma Inc.'s LP-284 has been awarded orphan drug designation by the FDA for the treatment of mantle cell lymphoma (MCL). LP-284 is a novel small-molecule agent that preferentially damages DNA in cancer cells harboring mutations in DNA damage repair pathways.
  • Gene therapy adeno associated virus aav
    Dec. 23, 2022

    Belief's gene therapy candidate BBM-H803 for hemophilia A awarded US orphan drug designation

    The FDA has awarded orphan drug designation to Belief Biomed Inc.'s BBM-H803 injection for the treatment of hemophilia A.
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