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 ...

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

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

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

The FDA has approved a 200 mg/mL autoinjector of belimumab (Benlysta) for at-home subcutaneous use in children aged 5 years ...