--Complete Response Letter (CRL) cited deficiencies previously identified at a third-party manufacturing vendor unrelated to Oxylanthanum Carbonate (OLC) --No other concerns stated, including pre-clinical, clinical, or safety data --The Company identified a second manufacturing vendor that has already produced OLC drug product, which could also be used to support the resolution of the Clinical Manufacturing and Controls (CMC) issues identified in the CRL --The Company plans to immediately request a Type A ...

- The U.S. Food and Drug Administration (FDA) identified deficiencies at a third-party manufacturing vendor - FDA to provide final decision by PDUFA action date of June 28, 2025 LOS ALTOS, Calif., June 10, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY or the “Company”), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced an update on its New Drug Application (NDA) for oxylanthanum carbonate (OLC) to treat hyperphosphatemia in pa ...

WALTHAM, Mass., March 31, 2025 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first- in-class medicines that meet significant unmet medical needs, today announced that an abstract detailing a post- hoc analysis of the OPTIMIZE Study, an open-label clinical trial of XPHOZAH ® (tenapanor), was accepted as a poster presentation at the National Kidney Foundation (NKF) Spring Clinical Meetings, to be held Apr ...