Ardelyx’s Tenapanor Hits Another Regulatory Stumbling Block On Label, Post-Marketing Commitments
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.
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Keeping Track: US FDA Approvals Of Saphnelo, Nexviazyme Balanced By CRLs For Rolontis, Treosulfan, Tenapanor
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
The company reported positive Phase III data from a second trial testing the first-in-class therapy as monotherapy for managing hyperphosphatemia in patients on dialysis.