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Keeping Track: Clarus, Agile and Sunovion Look To Bounce Back From CRLs; FDA To Review Rituximab Biosimilar

 
• By Michael Cipriano

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

Keeping Track Feature image

Class 2 resubmissions was the theme of the week, as several companies are looking to change their fortunes after receiving complete response letters from the US FDA.

Clarus Therapeutics Inc. has resubmitted its new drug application (NDA) for Jatenzo (testosterone undecanoate) after completing an additional Phase III trial, while Agile Therapeutics Inc. resubmitted the NDA...

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