GSK Wins First-Ever Voucher Race With Anti-Malarial Approval
US FDA’s approval of tafenoquine for malaria settled a first-of-its-kind race: GSK beat 60 Degrees to market to claim a priority review voucher.
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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.
Keeping Track: A Glut Of Big Approvals While Lartruvo Makes Its Market Exit
The latest drug development news and highlights from our US FDA Performance Tracker.
US FDA’s Record Tally Of NMEs Outpaces Ability To Issue Press Releases
US FDA may have set record for new drug approvals during 2018, but agency actually issued press releases highlighting approvals less often than it has in the past.