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Recent And Upcoming FDA Advisory Committee Meetings

Executive Summary

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered. 

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

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.

The Long And Short Of Accelerated Approval Accountability In US

The latest accelerated approval withdrawals in the US are milestones for accountability in the program – most notably with the withdrawal of an antimicrobial with confirmatory studies more than a decade overdue.

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Based on promising Phase II data, two companies in South Korea are moving ahead with late-stage development in the gout space, with JW Pharmaceutical getting approvals to begin a multinational Phase III trial for epaminurad, while LG Chem has recently submitted an application for a Phase III program with its contender tigulixostat.

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