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REGENXBIO Announces Initiation of Second Pivotal Trial in RGX-314 Clinical Program for the Treatment of Wet AMD Using Subretinal Delivery - Vimarsana News

REGENXBIO Announces Initiation of Second Pivotal Trial in RGX-314 Clinical Program for the Treatment of Wet AMD Using Subretinal Delivery

/PRNewswire/ -- ASCENTTM, a Phase III clinical trial conducted in partnership with AbbVie, is expected to enroll patients in the United States and Canada...

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 - Vimarsana News

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

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 T...

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 - Vimarsana News

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

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 ...

Cara Therapeutics and Vifor Pharma announce U.S. FDA acceptance and Priority Review of NDA for ... - Vimarsana News

Cara Therapeutics and Vifor Pharma announce U.S. FDA acceptance and Priority Review of NDA for ...

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 a...

Source: apnews.com
Cara Therapeutics Submits New Drug Application to U.S. Food and Drug Administration for KORSUVA™ Injection in Hemodialysis Patients with Moderate-to-Severe Pruritus - Vimarsana News

Cara Therapeutics Submits New Drug Application to U.S. Food and Drug Administration for KORSUVA™ Injection in Hemodialysis Patients with Moderate-to-Severe Pruritus

TMCnet News Cara Therapeutics Submits New Drug Application to U.S. Food and Drug Administration for KORSUVA™ Injection in Hemodialysis Patients with Moderate-to-Severe Pruritus [December 28, 2020] Cara Therapeutics Submits New Drug Application to U.S. Food and Drug Administration for KORSUVA™ Injection in Hemodialysis Patients with Moderate-to-Severe Pruritus First NDA submission for Company’s lead program, KORSUVA™ Injection – NDA submission includes request for Priority Review under Breakthrough Therapy Designation for KORSUVA Injection – STAMFORD, Conn., Dec. 28, 20...

Source: tmcnet.com