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FDA Turns Down Fast-Track Approval of AstraZeneca Cancer Drug
The Wall Street Journal (online registration required): AstraZeneca PLC failed to win accelerated approval of a cancer drug in the U.S., dealing a blow to its new drug-development pipeline, a key plank of its defense in fighting off a $120 billion approach from Pfizer Inc. last month.
The company said an advisory committee to the U.S. Food and Drug Administration voted 11 to 2 against accelerated approval of its experimental ovarian cancer drug olaparib in patients with a specific...
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