Moleculin Announces Positive Data in Annamycin MB-106 Phase 1B/2 AML Trial
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HOUSTON, Oct. 2, 2023 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a growing pipeline, including Phase 2 clinical programs, for hard-to-treat cancers and viruses, today announced the initial subjects have been treated in the Phase 2 portion of the Company's Phase 1B/2 trial evaluating Annamycin in combination with Cytarabine (Ara-C) for the treatment of subjects with AML (MB-106).
July 20 (Reuters) - Daiichi Sankyo (4568.T) said the U.S. health regulator has approved its drug for treating newly diagnosed patients suffering from an aggressive type of blood cancer, pitting the treatment against those from rivals Novartis (NOVN.S) and Astellas (4503.T).
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TOKYO & BASKING RIDGE, N.J.--(BUSINESS WIRE)--Daiichi Sankyo (TSE: 4568) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) of quizartinib in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as continuation monotherapy following consolidation, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive.
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The Agenzia Italiana del Farmaco (AIFA, the Italian Medicines Agency competent authority) and the Istituto Superiore di Sanità (ISS, the Italian National Institute of Health) have granted approval for Moleculin Biotech to begin its Phase I/II clinical trial of Annamycin plus Cytarabine (Ara-C) to treat acute myeloid leukemia (AML).