US FDA’s Scorching August Agenda
Ten novel agents are among the pending applications with user fee goal dates in August 2018.
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Keeping Track: Novel Approvals For Diacomit, Takhzyro And Oxervate; CRLs For Mallinckrodt And Allergan
The latest drug development news and highlights from our US FDA Performance Tracker.
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.
US FDA Likely To Shatter Novel Approval Record In 2018
With at least 40 pending novel products, FDA seems poised to break its 2017 approval record of 46, and could even reach 60.