The Food and Drug Administration on Aug. 23 approved Cara Therapeutics’ drug to treat moderate-to-severe itching in patients with chronic kidney disease undergoing dialysis, making Korsuva the first therapy for the ailment in the United States.

After receiving a Complete Response Letter (CRL) from the U.S. Food and Drug Administration for the New Drug Application for tenapanor for control of serum phosphorus in adults with chronic kidney disease on dialysis, Waltham, Mass.-based Ardelyx is restructuring to save money.

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 Phase III development program this weekend at the American Society of Nephrology (ASN) Kidney Week 2020 Reimagined conference. The analyses looked at associations between the […]