The drug is the only candidate to receive FDA breakthrough designation in the condition, and was granted the status based on phase 2 trial data from patients with IgA nephropathy and other kidney ...

Otsuka is hoping to file for approval of its anti-APRIL antibody sibeprenlimab as a treatment for kidney disorder IgA nephropathy (IgAN) after the drug hit the target in a phase 3 trial.

Vertex Pharmaceuticals (NASDAQ: VRTX) just snagged its second U.S. Food and Drug Administration (FDA) approval in only 41 ...

Renalys Pharma completes patient enrollment in registrational phase III trial of sparsentan for IgA nephropathy in Japan: Tokyo, Japan Friday, January 31, 2025, 18:00 Hrs [IST] Re ...

"IgA nephropathy is the most common cause of glomerulonephritis ... and maintain necessary approvals from the U.S. Food and Drug Administration and other regulatory authorities; obtaining and ...

IgA nephropathy is widely known as one of the ... the company aims to address the growing problem of "drug loss" by catalyzing access to new treatments for kidney disease patients in Japan and ...

Renalys Pharma, Inc. (Headquarters: Chuo-ku, Tokyo; "Renalys Pharma") announced today that it has completed patient enrollment for its registrational Phase III clinical trial of sparsentan for the ...