The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for ziftomenib as a treatment for adult patients with relapsed or refractory (R/R) acute myeloid ...

If approved, ziftomenib could be the first FDA-approved Menin inhibitor for relapsed/refractory acute myeloid leukemia with ...

The FDA set a PDUFA date in late 2025 as ziftomenib led to significant disease response in patients with common subtype of ...

CR/CRh rate of 23% in pivotal Ph 2 cohort of R/R NPM1-m AML patients – – Consistent efficacy with comparable CR/CRh rates and clinically meaningful MRD-negative responses across pre-specified ...

Kura Oncology and Kyowa Kirin have shared details of the phase 2 win for their oral leukemia treatment ziftomenib as the FDA ...

The U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for ziftomenib, an investigational ...

An international clinical trial co-led by Roswell Park Comprehensive Cancer Center has demonstrated that the investigational ...

(RTTNews) - Kura Oncology Inc. (KURA) and Kyowa Kirin Co., Ltd. announced the U.S. Food and Drug Administration has accepted Kuras New Drug Application or NDA seeking full approval for ziftomenib as a ...

Omeros faces critical liquidity challenges, with limited cash runway and rising dilution risks. Its cash runway is ...

Faculty from Roswell Park Comprehensive Cancer Center are among the international experts invited to share their research findings at the American Society of Clinical Oncology (ASCO) annual meeting ...

An international study has uncovered why a widely used treatment for acute myeloid leukemia (AML) doesn't work for everyone. The findings could help doctors better match patients with the therapies ...