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Daiichi Sankyo Announces Outcome of FDA Oncologic Drugs Advisory Committee Meeting to Review FLT3 Inhibitor Quizartinib for the Treatment of Patients with Relapsed/Refractory FLT3-ITD AML drugs
May 20, 2019
Daiichi Sankyo Announces Outcome of FDA Oncologic Drugs Advisory Committee Meeting to Review FLT3 Inhibitor Quizartinib for the Treatment of Patients with Relapsed/Refractory FLT3-ITD AML.
FDA advisory panel votes against Daiichi Sankyo’s quizartinib pharmaceutical-technology
May 16, 2019
A cancer advisory committee of the US Food and Drug Administration (FDA) has voted against Daiichi Sankyo’s quizartinib, which is indicated to treat adults with relapsed / refractory FLT3-internal tandem duplication (ITD) acute myeloid leukaemia (AML).
ODAC Votes No on Quizartinib as Relapsed/Refractory FLT3-ITD AML Treatment americanpharmaceuticalreview
May 16, 2019
Daiichi Sankyo Company announced the outcome of the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) to ...
FDA Grants Priority Review for Daiichi Sankyo's NDA for FLT3 Inhibitor Quizartinib americanpharmaceuticalreview
November 29, 2018
Daiichi Sankyo announced the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) and granted Priority Review for quizartinib for the treatment....
Quizartinib Receives Orphan Drug Designation from Japanese MHLW americanpharmaceuticalreview
September 12, 2018
Daiichi Sankyo Company announced quizartinib, an investigational FLT3 inhibitor, has been granted Orphan Drug designation by the Japan Ministry of Health, Labour and Welfare (MHLW) for the treatment of FLT3-mutated acute myeloid leukemia (AML).
FDA Grants Breakthrough Therapy Designation to Quizartinib fiercepharma
August 02, 2018
Daiichi Sankyo announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to quizartinib, an investigational FLT3 inhibitor, for the treatment of adult patients with relapsed/refractory FLT3-ITD acute myeloid leukem