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

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 ...

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

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

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 ...

Potential first approval of a menin inhibitor for the treatment of adult patients with relapsed or refractory AML with an NPM1 mutation – SAN DIEGO and TOKYO, June 01, 2025 (GLOBE NEWSWIRE ...

Potential first approval of a menin inhibitor for the treatment of adult patients with relapsed or refractory AML with an NPM1 mutation – “The FDA’s acceptance of our New Drug Application ...

(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 ...