Breaking News, Trials & Filings

Jazz Pharmaceuticals’ Vyxeos Granted Accelerated Assessment

Phase III results demonstrate a statistically significant improvement in overall survival for versus standard of care

Jazz Pharmaceuticals plc has filed a Marketing Authorization Application (MAA) to the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for Vyxeos powder for concentrate for infusion to treat adults with high-risk acute myeloid leukemia (AML) defined as therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC).   The CHMP granted Vyxeos accelerated assessment, which is designed to reduce the review timeline for products of major inte...

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