Drug receives breakthrough designation for relapsed/refractory AML



AML cells
The US Food and Drug Administration (FDA) has granted GMI-1271 breakthrough therapy designation for the treatment of adults with relapsed/refractory acute myeloid leukemia (AML). GMI-1271 is an E-selectin antagonist being developed by GlycoMimetics, Inc. The product already has orphan and fast track designations from the FDA for the treatment of AML. GMI-1271... [Read Article]

FDA approves midostaurin to treat FLT3+ AML, advanced SM



Midostaurin (Rydapt) capsules
Photo courtesy of Novartis
The US Food and Drug Administration (FDA) has granted approval for the oral, multi-targeted kinase inhibitor midostaurin (Rydapt). The drug is now approved for the treatment of adults with advanced systemic mastocytosis (SM), including aggressive SM (ASM), SM with associated hematologic neoplasm (SM-AHN), and mast cell... [Read Article]