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Ardelyx Receives Complete Response Letter from U.S. FDA for New Drug Application for Tenapanor for the Control of Serum Phosphorus in Adult Patients with CKD on Dialysis drugs
August 04, 2021
Ardelyx today announced that it has received a Complete Response Letter (CRL) from the FDA regarding the company's New Drug Application (NDA) for tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis.
Ardelyx Provides Regulatory Update on New Drug Application for Tenapanor for the Control of Serum Phosphorus in Adult Patients with CKD on Dialysis drugs
July 29, 2021
Ardelyx today announced that it received a letter from the U.S. Food and Drug Administration (the "FDA") on July 13, 2021, stating that, as part of its ongoing review of the company's NDA for the control of serum phosphorus in adult patients with CKD.
Ardelyx Announces NDA Acceptance of Tenapanor americanpharmaceuticalreview
September 22, 2020
Ardelyx announced the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) of tenapanor for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis.
Ardelyx Submits NDA for Tenapanor americanpharmaceuticalreview
July 10, 2020
Ardelyx announced the submission of a New Drug Application (NDA) for tenapanor to the U.S. Food and Drug Administration (FDA) for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis.
Ardelyx Appoints Renowned Nephrologist, Geoffrey A. Block, M.D., to Its Board of Directors firstwordpharma
March 15, 2019
Ardelyx, Inc. (NASDAQ: ARDX), today announced the appointment of Geoffrey A. Block, M.D., Vice President, Nephrology at Reata and former Director of Clinical Research in the Denver Nephrology Research Division at Colorado Kidney Care/Denver Nephrologists,
Ardelyx signs license agreement with Fosun Pharma for tenapanor in China manufacturing.pharmaceutical-business-review
December 13, 2017
Ardelyx has entered into a license agreement with Shanghai Fosun Pharmaceutical Industrial Development Company (Fosun Pharma) for tenapanor.
Unexpected Safety Issue Forces Bay Area's Ardelyx to Ditch Phase III Hyperkalemia Drug biospace
November 23, 2017
David Rosenbaum, Chief Debriefing Officer, Ardelyx, said: "Tenapanor will be the first non-phosphate-binding agent to treat hyperphosphatemia in dialysis patients with ESRD if approved.
Strong IBS and constipation Phase 3 data sends Ardelyx shares rocketing 60% pharmafile
October 13, 2017
Ardelyx has confirmed that its NHE3 inhibitor tenapanor met all its primary and secondary endpoints in the study of its treatment efficacy against irritable bowel syndrome and constipation (IBS-C).
Struggling Ardelyx cuts staff as it places bets on its late-stage pipeline fiercebiotech
August 10, 2017
The company has been stung by a series of trial setbacks and partners backing away.