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Orphan Drug Designation

News Orphan Drug Designation

  • Merck Announces FDA Orphan Drug Designation for Bifunctional Immunotherapy

    Merck announced that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to M7824, the first regulatory designation for the bifunctional immunotherapy, for the treatment of biliary tract cancer (BTC). The FDA orphan drug designation follows the recent presentation of more

  • Bioverativ to acquire biotechnology company True North Therapeutics

    Bioverativ Inc., a biotechnology company focused on the discovery, development and commercialization of innovative therapies for hemophilia and other rare blood disorders, announced that it has entered into a definitive agreement to acquire South San Francisco-based True North Therapeutics, a privat more

  • Merck and Pfizer Receive Positive Opinion from EMA Committee

    Merck and Pfizer announced that the European Medicines Agency (EMA)’s Committee for Orphan Medicinal Products (COMP) has issued a positive opinion for Orphan Drug designation (ODD) for avelumab*, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, pending an official decision by the more

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