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BRIEF-Array Biopharma announces FDA acceptance for review of Binimetinib and Encorafenib new drug applications for patients with advanced BRAF-mutant melanoma
2017年9月12日 / 下午1点18分 / 11 天前

BRIEF-Array Biopharma announces FDA acceptance for review of Binimetinib and Encorafenib new drug applications for patients with advanced BRAF-mutant melanoma

Sept 12 (Reuters) - Array Biopharma Inc

* Array Biopharma announces FDA acceptance for review of Binimetinib and Encorafenib new drug applications for patients with advanced BRAF-mutant melanoma

* Array Biopharma Inc - ‍FDA informed array that based on their preliminary review of applications they have not identified any potential review issues​

* Array Biopharma Inc - ‍FDA set a target action date under pdufa of june 30, 2018 for both applications​

* Array Biopharma Inc - ‍fda informed array that they are not currently planning to hold an advisory committee meeting to discuss NDAs​ Source text for Eikon: Further company coverage:

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