The U.S. Food and Drug Administration rejected Ardelyx Inc.’s chronic kidney disease drug tenapanor by issuing a Complete Response Letter.
The U.S. Food and Drug Administration sent a letter to Ardelyx Inc. citing “deficiencies” found in the company’s evaluation of the biopharmaceutical firm’s new drug to treat chronic kidney disease (CKD).
The United States Food and Drug Administration approved Bayer’s Kerendia (finerenone), a first-in-class nonsteroidal mineralocorticoid receptor antagonist indicated to reduce the risk of sustained eGFR decline, kidney failure, cardiovascular death, non-fatal myocardial infarction and hospitalization for heart failure in adult patients with chronic kidney disease associated with type 2 diabetes.
After the July 4 holiday, the U.S. Food and Drug Administration has several items on the regulatory agency’s immediate calendar, including a couple target action dates and an advisory committee hearing.
The U.S. Food and Drug Administration greenlit AstraZeneca’s Farxiga (dapagliflozin) under priority review for the treatment of chronic kidney disease in patients at risk of progression with or without type 2 diabetes.
Shares of FibroGen were down after the company unsuccessfully attempted to express confidence in the benefit/risk profile of its anemia drug roxadustat.
The U.S. Food and Drug Administration decided to put together an advisory committee meeting of outside experts to review a New Drug Application (NDA) for FibroGen and partner AstraZeneca’s investigational anemia therapy roxadustat.
FibroGen Provides More Support for Roxadustat in Anemia Associated with Kidney Disease Published: Oct. 26, 2020 By Mark Terry BioSpace FibroGen presented data from two pooled analyses from its roxadustat global […]
Shares of Cara Therapeutics were up in trading after the company struck a licensing agreement worth up to $290 million with Switzerland’s Vifor Pharma for the commercialization of a treatment for severe itching associated with chronic kidney disease.
Cambridge, Massachusetts-based Akebia Therapeutics announced topline results for PRO2TECT, the second of two Phase III cardiovascular outcomes programs evaluating the company’s vadadustat for treatment of anemia caused by chronic kidney disease in adults not on dialysis.
