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Moleculin Announces Additional Positive Interim Results in Studies of Annamycin in AML in Europe americanpharmaceuticalreview
May 08, 2019
Moleculin Biotech announced additional positive interim safety and efficacy data from its ongoing open label, single arm Phase 1/2 study of Annamycin in Poland.
Agios Announces FDA Approval of Tibsovo as Monotherapy for Newly Diagnosed Adult Patients with IDH1 Mutant Acute Myeloid Leukemia (AML) Not Eligible for Intensive Chemotherapy drugs
May 08, 2019
Agios Pharmaceuticals, Inc., a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, today announced the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) to ...
FDA Approves Ivosidenib as First-Line Treatment for AML with IDH1 Mutation americanpharmaceuticalreview
May 05, 2019
The Food and Drug Administration (FDA) has approved ivosidenib (TIBSOVO, Agios Pharmaceuticals) for newly-diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test.
EC grants orphan drug designation for Gilteritinib for the treatment of AML europeanpharmaceuticalreview
April 29, 2019
The European Commission has issued Orphan Designation to gilteritinib for the treatment of patients with acute myeloid leukaemia…
Moleculin Receives FDA Approval of Fast Track Designation for Annamycin americanpharmaceuticalreview
April 19, 2019
Moleculin Biotech announced that the U.S. Food and Drug Administration (FDA) has approved its request for Fast Track Designation for its drug, Annamycin, for the treatment of relapsed or refractory acute myeloid leukemia (AML).
Daiichi Sankyo Provides Update on Ongoing FDA Review for Quizartinib for Treatment of Patients with Relapsed/Refractory FLT3-ITD AML drugs
April 17, 2019
Daiichi Sankyo Provides Update on Ongoing FDA Review for Quizartinib for Treatment of Patients with Relapsed/Refractory FLT3-ITD AML.
SMC says ‘no’ to Novartis’ Kymriah for adults with lymphoma pharmatimes
March 12, 2019
Adults with lymphoma will not be able to access Novartis’ CAR-T therapy Kymriah on the NHS in Scotland after cost-regulators rejected funding for the treatment in this setting.
Turbulent times for Xencor as FDA slaps hold on AML bispecific fiercebiotech
February 22, 2019
Xencor didn’t have the best start to 2019—in January, its partner Novartis returned the rights to a bispecific antibody it had licensed as part of a 2016 deal worth up to $2.41 billion....
Drug compound could be next-generation treatment for aggressive form of leukemia worldpharmanews
January 30, 2019
Researchers have been struggling for years to find a treatment for patients who have a recurrence of acute myeloid leukemia (AML).
FDA Approves DAURISMO with Cytarabine for AML americanpharmaceuticalreview
December 28, 2018
he U.S. Food and Drug Administration (FDA) approved DAURISMO (glasdegib), in combination with low-dose cytarabine, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in .....

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