Amivas’ Malaria Drug Approval Brings Orphan Exclusivity, But Priority Review Voucher Status Unclear
Amivas requested a US tropical disease PRV for intravenous artesunate but FDA has not yet made a decision on eligibility; approval appears to block La Jolla’s competing product, currently under review, for seven years.
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Pfizer’s abrocitinib and Biogen/Eisai’s aducanumab are among a host of new investigational products that are under review by the European Medicines Agency.
Keeping Track Of Thanksgiving Leftovers: Risdiplam, Artesunate Highlight Glut Of Submissions/Filings
Yes, we know they should be out of the fridge by now, but here are the highlights of submissions and filings during the Thanksgiving week.
The latest drug development news and highlights from our US FDA Performance Tracker.