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October 13, 2016 07:00 ET | Source: Clinuvel Pharmaceuticals Limited

FDA, CLINUVEL to Discuss SCENESSE® at Pre-NDA Meeting

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...
July 18, 2016 08:11 ET | Source: Clinuvel Pharmaceuticals Limited

Clinuvel to file new drug with FDA

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...
July 06, 2016 08:00 ET | Source: Clinuvel Pharmaceuticals Limited

US FDA pathway opens to SCENESSE® following Fast Track designation for treatment of EPP

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 ...