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Keeping Track: A Novel Approval For Fluorodopa F 18, A Tentative Approval For Vumerity, And A Missed Goal Date For Zilretta

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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: Year-End Submissions Rush Brings Seven Novel Agents To US FDA

Highlights of year-end application submissions including candidates from AstraZeneca, BioMarin, Lilly, MorphoSys, and Seattle Genetics.

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CDER's 48 novel agents, including 35 in the second half of the year, marks the second-highest novel approval count in the contemporary era.

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