Unicycive Advances Drug Candidate Through FDA Review With Manufacturing Compliance Victory
Unicycive Therapeutics has cleared a major regulatory hurdle in its development of oxylanthanum carbonate, a potential treatment for hyperphosphatemia—a serious complication affecting dialysis patients with chronic kidney disease. The biotech firm resubmitted its New Drug Application to the FDA on Monday, marking a significant step forward after the agency's Complete Response Letter in June 2025.
The resubmission comes after the company's manufacturing partner successfully resolved compliance deficiencie
Unicycive Therapeutics has cleared a major regulatory hurdle in its development of oxylanthanum carbonate, a potential treatment for hyperphosphatemia—a serious complication affecting dialysis patients with chronic kidney disease. The biotech firm resubmitted its New Drug Application to the FDA on Monday, marking a significant step forward after the agency's Complete Response Letter in June 2025.
The resubmission comes after the company's manufacturing partner successfully resolved compliance deficiencie