FDA’s Advisory Committees Just Can’t Say “No”
Who says an advisory committee stop is a risky proposition? FDA’s advisors have voted in favor of approval on each of the last 12 products they’ve reviewed.
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Clovis Oncology Inc. on May 5 disclosed the FDA notified the company to expect its application for its experimental lung cancer drug rociletinib to be rejected – something that was widely expected on Wall Street after the firm failed in April to convince a federal panel of experts to back the medicine. Clovis, which is cutting its staff by 35% in the wake of the FDA's snub, now turns its attention to its investigational ovarian cancer drug rucaparib.