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.
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.
With at least 40 pending novel products, FDA seems poised to break its 2017 approval record of 46, and could even reach 60.