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BRIEF-Agios Submits Supplemental New Drug Application To FDA For Tibsovo (Ivosidenib Tablets) For Patients With Previously Trea

BRIEF-Agios Submits Supplemental New Drug Application To FDA For Tibsovo (Ivosidenib Tablets) For Patients With Previously Trea

Brief-Agios向FDA提交針對Tibsovo(Ivosidenib片)的補充新葯申請,用於既往治療的患者
路透社 ·  2021/03/01 22:09

March 1 (Reuters) - Agios Pharmaceuticals Inc :
   * AGIOS SUBMITS SUPPLEMENTAL NEW DRUG APPLICATION TO FDA FOR TIBSOVO® (IVOSIDENIB TABLETS) FOR PATIENTS WITH PREVIOUSLY TREATED IDH1-MUTANT CHOLANGIOCARCINOMA
   * AGIOS PHARMACEUTICALS - CO HAS REQUESTED PRIORITY REVIEW FOR APPLICATION OF TIBSOVO, WHICH, IF GRANTED, COULD RESULT IN A SIX-MONTH REVIEW PROCESS

Source text for Eikon:  Further company coverage:

((Reuters.Briefs@thomsonreuters.com;)

路透3月1日電-Agios PharmPharmticals Inc:*Agios向FDA提交TIBSOVO®(IVOSIDENIB片劑)的補充新葯申請,用於先前治療的IDH1突變膽管癌患者*Agios PharmPharmticals-CO已要求優先審查TIBSOVO的申請,如果獲得批准,可能需要6個月的審查過程Eikon的源文本:進一步的公司報道:(Reurs.Briefs@thomsonreurs.com;)

譯文內容由第三人軟體翻譯。


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