4:37 PM
Sep 12, 2017
 |  BC Extra  |  Company News

Regulatory round-up: Array, Sandoz, Sorrento, Adello

FDA accepted for review a number of applications, including NDAs from Array BioPharma Inc. (NASDAQ:ARRY) and BLAs for two biosimilar candidates.

FDA assigned a June 30, 2018 PDUFA date to a pair of NDAs from Array for binimetinib (MEK162) and encorafenib (LGX818) in combination to treat BRAF-mutant advanced, unresectable or metastatic melanoma. Last month, the company said it filed two NDAs since each compound will have...

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