Unicycive resubmits FDA NDA for oxylanthanum carbonate for dialysis CKD hyperphosphatemia
Unicycive Therapeutics resubmitted its FDA NDA for oxylanthanum carbonate phosphate to treat hyperphosphatemia in CKD patients on dialysis, including CMC data from a new manufacturing vendor. FDA issued no clinical efficacy or safety issues, with a new PDUFA date expected in six months after prior CRLs in June 2025 and