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.
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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.
Keeping Track: Thumbs Up For Doptelet And Palynziq, Thumbs Down For Methylene Blue MMX And Meloxicam
The latest drug development news and highlights from our US FDA Performance Tracker.
Although tafamidis has been stalled at FDA for transthyretin-mediated polyneuropathy, Pfizer may have found a different path toward US approval with cardiovascular outcomes data in cardiomyopathy.