Vifor Pharma
Vifor Pharma and Cara Therapeutics announce U.S. FDA acceptance and Priority Review of NDA for KORSUVA™ injection in hemodialysis patients with moderate-to-severe pruritus
Monday, March 8, 2021 1:10PM IST (7:40AM GMT)
St. Gallen, Switzerland & Stamford, Conn., United States:
FDA has set Prescription Drug User Fee Act (PDUFA) target action date of 23 August 2021
If approved, KORSUVA™ injection would be first therapy for treatment of pruritus in hemodialysis patients
Regulatory News:
Vifor Pharma and Cara Therapeutics, Inc. (Nasdaq: CARA) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the New Drug Application (NDA) for KORSUVA™ (difelikefalin) solution for injection for the treatment of moderate-to-severe pruritus in hemodialysis patients. The PDUFA target action date for KORSUVA™ is 23 August 2021. The FDA stated that
Vifor Pharma and Cara Therapeutics announce U.S. FDA acceptance and Priority Review of NDA for KORSUVA injection in hemodialysis patients with moderate-to-severe pruritus
If approved, KORSUVA injection would be first therapy for treatment of pruritus in hemodialysis patients
Regulatory News:
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210307005039/en/
Vifor Pharma and Cara Therapeutics, Inc. (Nasdaq: CARA) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the New Drug Application (NDA) for KORSUVA (difelikefalin) solution for injection for the treatment of moderate-to-severe pruritus in hemodialysis patients. The PDUFA target action date for KORSUVA is 23 August 2021. The FDA stated that currently it is not planning to hold an advisory committee meeting to discuss the application.
Press release content from Globe Newswire. The AP news staff was not involved in its creation.
Cara Therapeutics and Vifor Pharma announce U.S. FDA acceptance and Priority Review of NDA for .
Cara Therapeutics, Inc.March 8, 2021 GMT
FDA has set Prescription Drug User Fee Act (PDUFA) target action date of August 23, 2021
If approved, KORSUVA™ injection would be first therapy for treatment of pruritus in hemodialysis patients
STAMFORD, Conn, and ST. GALLEN, Switzerland, March 08, 2021 (GLOBE NEWSWIRE) Cara Therapeutics (Nasdaq:CARA) and Vifor Pharma today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the New Drug Application (NDA) for KORSUVA™ (difelikefalin) solution for injection for the treatment of moderate-to-severe pruritus in hemodialysis patients. The PDUFA target action date for KORSUVA is August 23, 2021. The FDA stated that currently it is not planning to hold an advisory committee meeting to discuss the
Ardelyx Reports Fourth Quarter and Full Year 2020 Financial Results and Recent Highlights
Company well positioned for PDUFA date of April 29, 2021 and the potential launch of tenapanor
News provided by
Share this article
Share this article
FREMONT, Calif. and WALTHAM, Mass., March 8, 2021 /PRNewswire/ Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company focused on developing innovative first-in-class medicines to improve treatment for people with kidney and cardiorenal diseases, today reported business highlights and financial results for the fourth quarter and full year ended December 31, 2020. The stage is set for an exciting year for Ardelyx in 2021 said Mike Raab, president and chief executive officer at Ardelyx. With our PDUFA date of April 29 rapidly approaching, we are well positioned and well prepared to commercialize tenapanor upon potential FDA approval of the first and only phosphate absorption inhibitor for the control of serum phosphorus. In addition,
Ardelyx Reports Fourth Quarter and Full Year 2020 Financial Results and Recent Highlights prnewswire.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from prnewswire.com Daily Mail and Mail on Sunday newspapers.