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Dispute Resolved? Ardelyx’s Tenapanor Gets US FDA Panel Nod For Dialysis Patients

 
• By Sue Sutter

Tenapanor could be an option for dialysis patients who cannot tolerate phosphate binder therapy or who need more help in reaching their serum phosphorous targets, advisory committee members said; Office of New Drugs director Peter Stein is expected to rule on Ardelyx’s appeal of a complete response letter within 30 days.

Ocean tide
Positive adcomm vote may have turned the tide on tenapanor's approval prospects in chronic kidney disease. • Source: Shutterstock

A US Food and Drug Administration advisory committee on 16 November took a strongly favorable view of Ardelyx Inc.’s Xphozah (tenapanor) for reducing serum phosphorous levels in dialysis patients, waving aside agency reviewers’ concerns about the magnitude of treatment effect and tolerability.

The Cardiovascular and Renal Drugs Advisory Committee overwhelming voted that the phosphate absorption inhibitor’s benefits outweigh its risks in controlling...

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Slowdown: US FDA’s 2025 Novel Approvals Are On Below-Average Pace

 
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Global Pharma Guidance Tracker - June 2025

 
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Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

US FDA’s CRL Release More Incremental Than ‘Radical’ Transparency

 
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