Innovative drug launched for rare, isolating, “light intolerance” disorder
April 16, 2020 02:53 ET
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Clinuvel Pharmaceuticals Limited
MELBOURNE, Australia and MENLO PARK, Calif., April 16, 2020 (GLOBE NEWSWIRE) -- Americans living with a rare genetic disorder that forces them to choose between self-isolation in the dark, or...
Phase II study: SCENESSE® in combination with narrowband ultraviolet B (NB-UVB) achieves repigmentation in vitiligo
December 19, 2018 06:38 ET
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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
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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
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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 reaches agreement on German SCENESSE® pricing through AMNOG Arbitration Board
April 12, 2017 05:09 ET
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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
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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
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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
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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 ...