Keeping Track: So. Much. News.
Executive Summary
The latest drug development news and highlights from our US FDA Performance Tracker.
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Agile's Twirla Suffers Scathing Critique By US FDA Ahead Of Advisory Cmte.
Agile's transdermal contraceptive will go before the Bone, Reproductive and Urologic Drugs Advisory Committee as it nears the end of its third review cycle, although the agency appears ready to issue another complete response letter before it even hears from the panel.
Keeping Track: Resubmissions For Tlando And Twirla NDAs, And A BTD For Pomalyst
The latest drug development news and highlights from our US FDA Performance Tracker.
Keeping Track: Mylan Wins First US FDA Approval For Neulasta Biosimilar, But Lands A CRL For Insulin Glargine; Genentech Nabs Broad Full Approval For Venclexta, PV Indication For Rituxan
The latest drug development news and highlights from our US FDA Performance Tracker.