FDA denies Unicycive's NDA for Oxylanthanum Carbonate due to vendor issues; company eyes quick resolution with alternate ...

Unicycive Therapeutics has hit a bump on the road in its mission to bring its hyperphosphatemia treatment candidate to ...

FDA issues a complete response letter for oxylanthanum carbonate, a treatment for hyperphosphatemia in patients with chronic ...

Unicycive, which was seeking approval of oxylanthanum carbonate to treat hyperphosphatemia in patients with chronic kidney disease on dialysis, said the FDA issued a so-called complete response letter ...

In a first step toward FDA approval of kidney xenotransplantation, a living human with end-stage kidney disease may receive a ...

Sangamo Therapeutics’ investigational gene therapy appears to improve kidney function at 52 weeks for patients with a rare ...

The U.S. Food & Drug Administration (FDA) has granted approval for a new subcutaneous autoinjector formulation of belimumab ...

Belimumab is now the first and only subcutaneous biologic therapy approved for at-home administration in pediatric lupus nephritis.