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Clinuvel Pharmaceuticals LimitedASX: CUV

US FDA Update

Sep 4, 2018 at 11:39 PM EDT · Issued by Clinuvel Pharmaceuticals Limited

Filed with ASX · Sep 4, 2018 at 11:39 PM EDT · 3 pages · English

On 6ix: 6ix.com/news/us-fda-update

Watch Clinuvel Pharmaceuticals' latest callClinuvel Pharmaceuticals (ASX:CUV) Q4 2026 Earnings Call · Replay · Aug 27↗

Clinuvel Pharmaceuticals Limited on 6ix

Story so far

  • CLINUVEL completes SCENESSE FDA FilingJun 25, 2018
  • CLINUVEL provides update on SCENESSE FDA filingSep 19, 2017
  • CLINUVEL agrees with FDA on New Drug Application timelinesNov 9, 2016

Earlier from Clinuvel Pharmaceuticals

  • CLINUVEL completes SCENESSE FDA FilingJun 25, 2018
  • NICE maintains position not to recommend SCENESSEMay 22, 2018
  • CLINUVEL Regulatory UpdateMay 13, 2018
  • CLINUVEL to take 100% ownership of VALLAURIX joint ventureMay 1, 2018
  • CLINUVEL hosts European EPP Expert MeetingMar 18, 2018

Later from Clinuvel Pharmaceuticals

  • S&P DJI Announces September 2018 Quarterly RebalanceSep 6, 2018
  • Appeal Upheld Against NICE Recommendation in EnglandOct 9, 2018
  • CUV103 Singaporean Phase II vitiligo study resultsDec 18, 2018
  • US FDA sets PDUFA date for SCENESSEJan 9, 2019
  • US FDA extends PDUFA date for SCENESSEJun 2, 2019
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