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Fast Track Status

News Fast Track Status

  • Merck and Pfizer Receives FDA Fast Track Designation

    Merck and Pfizer announced that the US Food and Drug Administration (FDA) has granted avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, Fast Track designation for the treatment of metastatic Merkel cell carcinoma (MCC), a rare and aggressive type of skin cancer. This anno more

  • TxCell receives Fast Track Designation from FDA for Ovasave

    TxCell SA announced  that the United States Food and Drug Administration (FDA) has granted Fast Track Designation to TxCell’s lead product Ovasave(R) for the treatment of moderate to severe Crohn’s disease. Ovasave already has an active IND (Investigational New Drug) with the FDA. The FDA Fast Track more

  • Merck Receives FDA Fast Track Designation for Evofosfamide

    Merck announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of evofosfamide (previously known as TH-302), administered in combination with gemcitabine, for the treatment of previously untreated patients with metastatic or locally advanced u more

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