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Latest From Tricida, Inc.
Keeping Track: US FDA Has Clinical Questions For Tricida, Gilead And BioMarin; Enspryng And Winlevi Approved
The latest drug approval and decision news from the Pink Sheet’s US FDA Performance Tracker.
FDA may be evaluating the future of accelerated approval, but data from the Pink Sheet’s Performance Tracker shows growth in the submissions and approvals over the past five years.
US FDA advisory committee meetings held in close proximity to user fee goal dates are approved at a similar rate to all products reviewed by the advisory panels, according to a Pink Sheet analysis of drug and biologic advisory committees since 2015.
Almost 50 novel agents are already under review at FDA for potential 2020 approval. Candidates are notably diverse, with concentrations in established strongholds (oncology, neuroscience), popular programs (breakthrough), and powerhouse sponsors (keep an eye on Bristol-Myers Squibb right out of the gate).