source
- FDA gene and cell therapy review office loses acting director Vijay KumarVijay Kumar has announced he will step down from his role as acting director of the Office of Gene and Cell Therapy Reviews within the FDA's Center for Biologics Evaluation and Research. Karim Mik…
- Unicycive Therapeutics receives second FDA complete response letter for kidney drug amid manufacturing problemsUnicycive Therapeutics' chronic kidney disease drug, a phosphate binder called oxylanthanum carbonate (OLC), has been rejected by the U.S. Food and Drug Administration for a second time. The FDA c…