Priority Review Designations In US: Third Quarter Spike Continues In 2017
Third quarter saw record total of 26 announcements for priority review designations; drop-off now likely.
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Breakthrough, Priority Review Designations Could Set High-Water Marks In 2018
Announcements of designations for both US FDA's expedited pathway are on torrid paces through first half of 2018.
Breakthrough Therapy Designations Set Quarterly Record
US FDA granted designations for several products based on late-stage data; with at least 19 breakthrough therapy designations, five-year-old program sets another record in first quarter of 2018.
US FDA Sets Records With Breakthrough Therapy, Priority Review Designations In 2017
Cancer therapies captured a majority of both the breakthrough therapy and priority review designations awarded by the agency.