- cafead Dec 30, 2022 at 10:52: AM
via The FDA bestowed good tidings upon Ardelyx’s experimental chronic kidney disease drug Thursday morning.
Regulators told the biotech they would hear an appeal to its complete response letter, potentially setting Ardelyx up for an approval resubmission in the first half of next year. The move follows a post-CRL advisory committee meeting last month in which the FDA’s Cardiovascular and Renal Drugs panelists voted in favor of both monotherapy and combination regimen approvals.
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Regulators told the biotech they would hear an appeal to its complete response letter, potentially setting Ardelyx up for an approval resubmission in the first half of next year. The move follows a post-CRL advisory committee meeting last month in which the FDA’s Cardiovascular and Renal Drugs panelists voted in favor of both monotherapy and combination regimen approvals.
article source