The FDA announced what made Clovis Oncology (CLVS) shareholders believe that the bad times might have ended for the firm and a new era is beginning. The announcement was about the FDA decision not to hold an advisory committee meeting to discuss the company’s New Drug Application (NDA) for drug rucaparib aimed at treating advanced ovarian cancer.
The regulatory agency had already granted rucaparib a breakthrough and priority reviewstatuses, and had set the PDUFA date for Feb. 23, 2017. The regulatory agency is currently reviewing rucaparib for patients . . .
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Today’s Highlights September 12, 2016