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November 30, 2018 03:00 ET | Source: Invivoscribe, Inc.

FDA ของสหรัฐฯ อนุมัติให้ LeukoStrat CDx FLT3 Mutation Assay ของ Invivoscribe เป็น CDx และให้ยา XOSPATA (gilteritinib fumarate) ของ Astellas ใช้รักษาผู้ป่วยมะเร็งเม็ดเลือดขาวชนิดเฉียบพลันแบบไมอีลอยด์ (AML) ในสหรัฐอเมริกาได้

ซานดิเอโก, Nov. 30, 2018 (GLOBE NEWSWIRE) -- Invivoscribe มีความยินดีที่จะประกาศว่า องค์การอาหารและยาสหรัฐฯ (FDA) ได้อนุมัติให้ทั้ง LeukoStrat CDx FLT3 Mutation Assay และยา XOSPATA (gilteritinib...
November 30, 2018 03:00 ET | Source: Invivoscribe, Inc.

FDA dos EUA aprova o Exame de mutação LeukoStrat CDx FLT3 da Invivoscribe como CDx e o medicamento XOSPATA (fumarato de gilteritinib) da Astellas para tratamento de pacientes com LMA nos EUA

SAN DIEGO, Nov. 30, 2018 (GLOBE NEWSWIRE) -- A Invivoscribe tem o prazer de anunciar a aprovação pela FDA do Exame de mutação LeukoStrat CDx FLT3 e do medicamento XOSPATA (fumarato de gilteritinib),...
November 30, 2018 03:00 ET | Source: Invivoscribe, Inc.

米国FDA、AML患者の治療のために、インビボスクライブのルーコストラットCDx FLT3変異アッセイをCDxとして承認し、アステラスの医薬品であるゾスパタ (ギルテリチニブフマル酸塩) を承認

サンディエゴ発, Nov. 30, 2018 (GLOBE NEWSWIRE) -- インビボスクライブ (Invivoscribe) は、米国の難治性/再発性FLT3陽性急性骨髄性白血病 (AML) 患者の治療のために、FDA (食品医薬品局) がルーコストラット (LeukoStrat) CDx FLT3変異アッセイ、およびアステラス製薬 (Astellas Pharma Inc.)...
November 30, 2018 03:00 ET | Source: Invivoscribe, Inc.

FDA AS menyetujui Asai Mutasi Invivoscribe LeukoStrat CDx FLT3 sebagai XOSPATA (fumarat gilteritinib) obat CDx dan Astellas untuk pengobatan pasien AML di AS

SAN DIEGO, Nov. 30, 2018 (GLOBE NEWSWIRE) -- Invivoscribe dengan senang hati mengumumkan persetujuan FDA baik Asai Mutasi LeukoStrat CDx FLT3 dan obat Astellas, XOSPATA (fumarat gilteritinib), untuk...
November 30, 2018 03:00 ET | Source: Invivoscribe, Inc.

美国FDA批准Invivoscribe LeukoStrat CDx FLT3基因突变试验和Astellas药物XOSPATA（富马酸吉列替尼）在美分别被用于伴随诊断和AML患者治疗

美国圣地亚哥, Nov. 30, 2018 (GLOBE NEWSWIRE) -- Invivoscribe十分高兴地宣布，FDA现已批准LeukoStrat CDx FLT3基因突变试验和Astellas的药物XOSPATA（富马酸吉列替尼）被用于治疗美国FLT3阳性的难治性或复发性急性骨髓性白血病（AML）患者。此外，日本MHLW已确认LeukoStrat CDx...
November 29, 2018 18:05 ET | Source: Invivoscribe, Inc.

Update -- US FDA approves Invivoscribe LeukoStrat CDx FLT3 Mutation Assay as CDx and Astellas drug XOSPATA (gilteritinib fumarate) for treatment of AML patients in the US

SAN DIEGO, Nov. 29, 2018 (GLOBE NEWSWIRE) -- Invivoscribe is pleased to announce FDA approval of both the LeukoStrat CDx FLT3 Mutation Assay and the Astellas drug, XOSPATA (gilteritinib fumarate),...
November 29, 2018 06:00 ET | Source: Invivoscribe, Inc.

US FDA approves Invivoscribe LeukoStrat CDx FLT3 Mutation Assay as CDx and Astellas drug XOSPATA (gilteritinib fumarate) for treatment of AML patients in the US

SAN DIEGO, Nov. 29, 2018 (GLOBE NEWSWIRE) -- Invivoscribe is pleased to announce FDA approval of both the LeukoStrat CDx FLT3 Mutation Assay and the Astellas drug, XOSPATA (gilteritinib fumarate),...
November 28, 2018 04:53 ET | Source: Invivoscribe, Inc.

Invivoscribe envia o Exame de mutação LeukoStrat CDx FLT3 nos EUA e no Japão para dar suporte aos envios do quizartinib pela Daiichi Sankyo

SAN DIEGO, Nov. 28, 2018 (GLOBE NEWSWIRE) -- Em suporte a uma contínua parceria com a Daiichi Sankyo, a Invivoscribe tem o prazer de anunciar os envios do Exame de mutação LeukoStrat® CDx FLT3 para...
November 28, 2018 04:53 ET | Source: Invivoscribe, Inc.

Invivoscribe在美国和日本提交LeukoStrat CDx FLT3突变检测，用以支持Daiichi Sankyo提交的Quizartinib申请

美国圣地亚哥, Nov. 28, 2018 (GLOBE NEWSWIRE) -- 为支持与Daiichi Sankyo的持续合作关系，Invivoscribe十分高兴地宣布，已向美国FDA和日本PMDA（制药和医疗器械机构）提交开展LeukoStrat® CDx FLT3 突变检测作为quizartinib的伴随诊断的申请。此前，Daiichi...
November 28, 2018 04:53 ET | Source: Invivoscribe, Inc.

Invivoscribe在美國和日本提交LeukoStrat CDx FLT3突變檢測，以支援Daiichi Sankyo所提交的Quizartinib申請

美國加州聖地牙哥, Nov. 28, 2018 (GLOBE NEWSWIRE) -- 為支援與Daiichi Sankyo的持續合作關係，Invivoscribe很高興宣佈，已向美國FDA和日本PMDA（製藥和醫療器械機構）提交開展LeukoStrat® CDx FLT3 突變檢測作為quizartinib的伴隨診斷的申請。此前， Daiichi...