Keeping Track: US FDA Enters Year's Final Stretch With Tsunami Of Novel Approvals
The latest drug development news and highlights from our US FDA Performance Tracker.
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Long Road For Daiichi Sankyo’s Quizartinib Gets Longer As FDA Extends Review Time
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Astellas Misses Again On Xospata Label Expansion Effort
A Phase III disappointment in a maintenance therapy setting for FLT3-mutated acute myeloid leukemia is yet another failed attempt by Astellas to add to Xospata’s label since US FDA approval in 2018.
Keeping Track Of Approvals: Two Novel Drugs (Givlaari And Xcopri), A Project Orbis Collaboration (Calquence) And Another Humira Biosimilar
The latest news on US FDA drug approvals.