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.
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Orphan drugs and priority reviews achieved historic highs in CDER's 2018 novel approval class, but share of products with breakthrough therapies took a slide.
Priority review announcements saw significant dip in third quarter 2018, while they usually experience a spike during the period; breakthrough therapy designations remained in double digits.
Announcements of designations for both US FDA's expedited pathway are on torrid paces through first half of 2018.