Novartis (NVS) announced the US FDA has approved Rydapt (midostaurin) for two indications. The first indication is for the treatment of acute myeloid leukemia in newly diagnosed patients who are FMS-like tyrosine kinase 3 mutation-positive, as detected by an FDA-approved test, in combination with chemotherapy. Rydapt is also approved to treat adults with advanced systemic mastocytosis, which includes aggressive systemic mastocytosis, systemic mastocytosis with associated hematological neoplasm and mast cell leukemia.
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