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Servier Announces FDA Approval of TIBSOVO (ivosidenib tablets) in IDH1-Mutated Cholangiocarcinoma firstwordpharma
August 26, 2021
Servier Pharmaceuticals announced today that the U.S. Food and Drug Administration approved TIBSOVO®(ivosidenib tablets) for the treatment of adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with an IDH1 mutation.
Servier Announces Positive Topline Data from the Global Phase 3 Study of TIBSOVO® (ivosidenib tablets) in Combination with Azacitidine in Patients with Previously Untreated IDH1-mutated Acute Myeloid prnasia
August 02, 2021
Servier, a global pharmaceutical company, today announced the global Phase 3 double blinded placebo controlled AGILE study of TIBSOVO (ivosidenib tablets) in combination with the chemotherapy azacitidine in adults with previously untreated ...
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 ...
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.
FDA approves Tibsovo americanpharmaceuticalreview
July 24, 2018
The U.S. Food and Drug Administration (FDA) approved Tibsovo (ivosidenib) tablets for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation.
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.