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Latest From Ardelyx Inc.
April User Fee Goal Calendar: Forecast Uncertain For Atopic Dermatitis Candidates, Nuplazid; Eohilia Could Be First For Orphan Use
While some of the most prominent applications with user fee goal dates in April could be delayed, thanks to JAK inhibitor safety concerns and US FDA communications, the upcoming month should see more than 15 decisions on applications.
Executives share their expectations and hopes around the multi-faceted topic of patient access to medicines. From health inequities to value assessment and reimbursement trends, expectations for change abound.
The latest application submission news and highlights from the Pink Sheet’s US FDA Performance Tracker.
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).