FDA Approves SCENESSE® For Genetic Disorder
October 08, 2019 19:11 ET
|
Clinuvel Pharmaceuticals Limited
MELBOURNE, Australia, Oct. 08, 2019 (GLOBE NEWSWIRE) -- The US Food and Drug Administration (FDA) has approved a new drug as the first ever treatment for a rare genetic metabolic disorder which...
US FDA sets PDUFA date for SCENESSE®
January 10, 2019 07:29 ET
|
Clinuvel Pharmaceuticals Limited
Executive summary New Drug Application submitted in accordance with section 505(b) of the Federal Food, Drug, and Cosmetic Act, filed in accordance with 21 CFR 314.101(a)Scientific exchange between...
Phase II study: SCENESSE® in combination with narrowband ultraviolet B (NB-UVB) achieves repigmentation in vitiligo
December 19, 2018 06:38 ET
|
Clinuvel Pharmaceuticals Limited
MELBOURNE, Australia and SINGAPORE, Dec. 19, 2018 (GLOBE NEWSWIRE) -- SUMMARY Phase II study in vitiligo, a treatment-resistant disease1n=21, patients of Asian ethnicity, darker skin...
CLINUVEL delivers second positive financial result
August 29, 2018 06:52 ET
|
Clinuvel Pharmaceuticals Limited
MELBOURNE, Australia, Aug. 29, 2018 (GLOBE NEWSWIRE) -- EXECUTIVE SUMMARY – FINANCIAL YEAR 01 JULY TO 30 JUNE 2017/182016/17ChangeTotal Revenues$25.750m$16.984m52%Net profit before income tax...
FDA to Review Australian Drug for Genetic Disorder of Absolute Light Intolerance
June 25, 2018 06:00 ET
|
Clinuvel Pharmaceuticals Limited
MELBOURNE, Australia, June 25, 2018 (GLOBE NEWSWIRE) -- In a landmark case, the US Food and Drug Administration (FDA) has begun a review of an innovative drug developed for patients who carry a rare...
CLINUVEL unveils new global positioning
February 19, 2018 22:47 ET
|
Clinuvel Pharmaceuticals Limited
MELBOURNE, Australia, Feb. 19, 2018 (GLOBE NEWSWIRE) -- CLINUVEL PHARMACEUTICALS LTD (ASX:CUV) (XETRA-DAX:UR9) (NASDAQ INTERNATIONAL DESIGNATION ADR:CLVLY) today released its new global Company...
CLINUVEL reaches agreement on German SCENESSE® pricing through AMNOG Arbitration Board
April 12, 2017 05:09 ET
|
Clinuvel Pharmaceuticals Limited
MELBOURNE, Australia and LEATHERHEAD, United Kingdom, April 12, 2017 (GLOBE NEWSWIRE) -- CLINUVEL PHARMACEUTICALS LTD (ASX:CUV) (XETRA:UR9) (OTC:CLVLY) today announced that it had reached agreement...
FDA, CLINUVEL to Discuss SCENESSE® at Pre-NDA Meeting
October 13, 2016 07:00 ET
|
Clinuvel Pharmaceuticals Limited
MELBOURNE, Australia and NEW YORK, Oct. 13, 2016 (GLOBE NEWSWIRE) -- CLINUVEL PHARMACEUTICALS LTD (ASX:CUV) (OTC:CLVLY) (XETRA:UR9) today announced that it will meet with the US Food and Drug...
Clinuvel to file new drug with FDA
July 18, 2016 08:11 ET
|
Clinuvel Pharmaceuticals Limited
MELBOURNE, Australia and NEW YORK, July 18, 2016 (GLOBE NEWSWIRE) -- Clinuvel Pharmaceuticals (ASX:CUV) (OTC:CLVLY) (XETRA:UR9) today announced that the US Food and Drug Administration (FDA) has...
US FDA pathway opens to SCENESSE® following Fast Track designation for treatment of EPP
July 06, 2016 08:00 ET
|
Clinuvel Pharmaceuticals Limited
FDA awards Fast Track Designation¹ to expedite review of SCENESSE® in EPPNDA filing allowed on a rolling basisFDA hosting a Scientific Workshop² on EPP to learn more about disease and drug treatment ...