Invokana Development Directed By Mechanism Of Action
This article was originally published in Pharmaceutical Approvals Monthly
J&J’s canagliflozin is the first approval for a new pharmacologic approach to diabetes treatment, so FDA and the sponsor looked closely at the mechanism of action to identify safety questions – and to structure a clinical program that would provide data to answer them in the first review cycle.
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Keeping Track: Tumor-Agnostic Approval For Novartis; Submissions From Krystal, Menarini, And Astellas
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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