News

FDA Raises Manufacturing Concerns, Delays Unicycive's Kidney Disease Drug Approval
FDA denies Unicycive's NDA for Oxylanthanum Carbonate due to vendor issues; company eyes quick resolution with alternate ...
Fierce Pharma5d
FDA hits Unicycive with manufacturing-related complete response letter, delaying hopes for kidney disease prospect
Unicycive Therapeutics has hit a bump on the road in its mission to bring its hyperphosphatemia treatment candidate to ...
The American Journal of Managed Care5d
Oxylanthanum Carbonate Fails to Secure FDA Approval for Hyperphosphatemia, CKD
FDA issues a complete response letter for oxylanthanum carbonate, a treatment for hyperphosphatemia in patients with chronic ...
Unicycive Shares Slide Premarket as FDA Rejects Oxylanthanum Carbonate Application
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 ...
Fierce Biotech11d
Sangamo preps FDA application for Fabry gene therapy on heels of phase 1/2 registrational data
Sangamo Therapeutics’ investigational gene therapy appears to improve kidney function at 52 weeks for patients with a rare ...
Healio8d
‘We need this’: Pig-to-human kidney transplants enter clinical trials
In a first step toward FDA approval of kidney xenotransplantation, a living human with end-stage kidney disease may receive a ...
Lupus Foundation of America10d
FDA Approves Benlysta Autoinjector for Treatment of Children with Lupus Nephritis
The U.S. Food & Drug Administration (FDA) has granted approval for a new subcutaneous autoinjector formulation of belimumab ...
Vera Therapeutics Shares Climb on Positive Trial Results for Kidney Disease Drug
Vera Therapeutics shares jumped in premarket trading Monday after the company said that its treatment for chronic kidney disease, also known as Berger's disease, has shown positive results in its ...