US FDA Sets Records With Breakthrough Therapy, Priority Review Designations In 2017
Executive Summary
Cancer therapies captured a majority of both the breakthrough therapy and priority review designations awarded by the agency.
You may also be interested in...
Orphan Drugs Compose Majority Of Novel US Approvals For First Time Ever In 2018
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 Reviews At US FDA: From Third Quarter Spikes To A Third Quarter Trough
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.
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.