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 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.
The latest drug development news and highlights from our US FDA Performance Tracker.
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.