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Agios Announces FDA Acceptance and Priority Review of New Drug Application for Mitapivat for Treatment of Adults with Pyruvate Kinase Deficiency
drugs
August 26, 2021
Agios Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for mitapivat for the treatment of adults with pyruvate kinase (PK) deficiency.
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Servier Acquires Agios Pharmaceuticals’ Oncology Portfolio
contractpharma
April 02, 2021
Servier, a global pharmaceutical company, has successfully completed its acquisition of Agios Pharmaceuticals' commercial, clinical and research-stage oncology portfolio for up to $2 billion plus royalties.
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Agios Submits sNDA for TIBSOVO for IDH1-Mutant Cholangiocarcinoma
americanpharmaceuticalreview
March 04, 2021
Agios Pharmaceuticals has submitted a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for TIBSOVO® (ivosidenib tablets) as a potential treatment for patients with previously treated isocitrate dehydrogenase 1 ...
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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 ...
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Agios receives nod for ivosidenib
biospectrumasia
October 11, 2018
Orphan Drug-tagged ivosidenib, an orally available IDH1 inhibitor, had Fast Track status.
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Agios, Celgene terminate partnership for developing cancer treatment
biospectrum
September 10, 2018
Agios Pharmaceuticals and Celgene have mutually agreed to terminate their collaboration and license agreement inked on April 27, 2015, to develop and commercialize products containing pan-IDH inhibitor AG-881.
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Agios wins FDA nod for targeted AML drug Tibsovo
fiercepharma
July 24, 2018
A year after its Celgene-partnered drug Idhifa won FDA approval to treat certain patients with relapsed/refractory acute myeloid leukemia, Agios Pharmaceuticals has scored its first FDA nod for a wholly-owned medicine, Tibsovo.
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US approves first-in-class targeted AML therapy
pharmatimes
July 24, 2018
US regulators have approved the first targeted therapy for patients with relapsed or refractory acute myeloid leukemia carrying a certain genetic mutation.