Ardelyx Reports China’s NMPA Approval of Tenapanor for Hyperphosphatemia in Patients

Shots:China’s NMPA has approved NDA of tenapanor for hyperphosphatemia in CKD pts on dialysis who inadequately responded or are intolerant to phosphorus binders Approval was based on data from 2 Fosun Pharma studies (PK study & pivotal trial in CKD pts on dialysis), plus clinical studies from Ardelyx Approval triggered $5M milestone…

ByRidhi RastogiFebruary 27, 2025

INSIGHTS+

Insights+: The US FDA New Drug Approvals in September and October 2019

The US FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 35 new products so far in 2019. In 2018 FDA approved 59 novel products including 42 New Chemical Entities and 17 Biologics while breaking its last year's record of approvals. However, there is a significant…

BySenior EditorNovember 15, 2019

Ardelyx Reports China’s NMPA Approval of Tenapanor for Hyperphosphatemia in Patients

Insights+: The US FDA New Drug Approvals in September and October 2019

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