Keeping Track: CDER Ties Monthly Novel Approval Record With Nourianz Green Light
Executive Summary
The latest drug development news and highlights from our US FDA Performance Tracker.
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CDER Reviewers Showcase Speed In 2019 With 11 Novel Drugs Approved Within Six Months
Median review time held steady in 2019, but the percentage of NDAs the US FDA approved within six months jumped compared to recent years, a performance upswing all the more impressive because of the relatively high number of applications involved.
Keeping Track: Industry Beefs Up 2020 Review Pipeline With Submissions Galore
The latest drug development news and highlights from our US FDA Performance Tracker.
Lilly's Taltz Approved For AS As New Guidelines Keep TNF Inhibitors In Front Line
VP Rebecca Morison said the ankylosing spondylitis indication adds more evidence of Taltz's benefits. She noted Lilly believes there should be fewer steps before AS patients access IL-17 inhibitors.