US precision therapy company Blueprint Medicines said that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion for avapritinib as a monotherapy for certain types of gastrointestinal stromal tumors (GIST). CHMP has recommended conditional marketing authorization of the kinase inhibitor in the European Union for […]
Blueprint Medicines said that the US Food and Drug Administration (FDA) has rejected its new drug application (NDA) for AYVAKIT (avapritinib) for the treatment of fourth-line gastrointestinal stromal tumor (GIST). The US precision therapy company received a complete response letter (CRL) from the FDA in this connection. Blueprint Medicines was seeking FDA approval for avapritinib […]
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