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Latest From Ardelyx Inc.
While not an outright rejection, the Deficiencies Preclude Discussion letter came as a surprise given the expectation of the drug’s approval for hyperphosphatemia in adults with chronic kidney disease on dialysis.
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.