Watching The Review Clock: Are US FDA Goal Date Extensions Reason For Optimism?

Novel agents that received three-month user fee goal date extensions have a slightly higher approval rate than novel applications overall.

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Biogen, Inc. and Eisai Co., Ltd.’s announcement of a three-month extension to the PDUFA goal date for the potential Alzheimer’s disease therapy aducanumab cast a spotlight on what is usually a fairly mundane regulatory event: a three-month extension to the goal date.

Analysts greeted the 29 January 2021 announcement of the new 7 June target with a degree of optimism, noting that...

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