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investigational new drug

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  • Q&A: Paradigm to answer FDA questions to achieve Investigational New Drug status
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  • Q&A: Paradigm to answer FDA questions to achieve Investigational New Drug status
    • News

    Q&A: Paradigm to answer FDA questions to achieve Investigational New Drug status

    The commercialisation of osteoarthritis treatment ZILOSUL® has hit a hiccup in the United States with the US Food and Drug Administration (FDA) raising fresh questions to late-stage drug development company, Paradigm Biopharmaceuticals (ASX: PAR). The FDA response related to Paradigm’s application for Investigational New Drug status to be granted for their focus compound, Pentosan Polysulfate

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  • Noxopharm receives FDA approval for testing of promising cancer treatment
    • News

    Noxopharm receives FDA approval for testing of promising cancer treatment

    Jennie Young was one of the first patients to receive Veyonda, Noxopharm’s (ASX: NOX) proprietary drug. Administered on compassionate grounds, her doctors believe that she responded to it positively. She had leiomyosarcoma, a rare cancer that affects smooth muscle tissue. Soft tissue sarcomas like hers have limited treatment options with only 14% responding to chemotherapy. 

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