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  • Eiger Announces Breakthrough Therapy Designation Granted by FDA for Lonafarnib americanpharmaceuticalreview
    December 19, 2018
    Eiger BioPharmaceuticals announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for lonafarnib for the treatment of hepatitis delta virus (HDV) infection......
  • FDA Grants Breakthrough Therapy Designation for Xolair americanpharmaceuticalreview
    August 14, 2018
    Genentech announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Xolair (omalizumab) for the prevention of severe allergic reactions following accidental exposure to one or more foods in people with allergie
  • FDA Grants Breakthrough Therapy Designation to DS-8201 americanpharmaceuticalreview
    August 30, 2017
    FDA has granted Breakthrough Therapy designation to DS-8201, an investigational HER2-targeting antibody drug conjugate (ADC), for the treatment of patients with HER2-positive
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