Vitrakvi, Daurismo Approvals Put US FDA On Brink Of Another Record
Executive SummaryNew oncologics bring CDER’s novel agent approvals count to 53 for the year.
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A positive opinion for its FLT3 inhibitor for acute myeloid leukemia gives Astellas a further advantage over its Japanese competitor's same-class offering, quizartinib.
The latest drug development news and highlights from our US FDA Performance Tracker.
It’s hard enough in the first place for companies to persuade the European Medicines Agency that their planned marketing authorization application should be fast-tracked. Many are also finding that after accelerated assessment is granted, it is taken away during the actual review.