Amarin Announces FDA Notification of Advisory Committee Meeting Planned to be Held in November 2019 in Connection With Vascepa® REDUCE-IT™ sNDA
Last amarin corp plc ads earnings: 4/30 05:00 am
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US:NASDAQ Investor Relations: investor.amarincorp.com/investors
PDUFA Date Extension to End of December 2019 Expected Management to Host Conference Call Today at 7:00 p.m. ET BEDMINSTER, N.J. and DUBLIN, Ireland, Aug. 08, 2019 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), a pharmaceutical company focused on improving cardiovascular health, announced today that it received notice today from the U.S. Food and Drug Administration (FDA) that the FDA plans to hold an advisory committee meeting (AdCom), tentatively scheduled for November 14, 2019, in connection with its review of the pending supplemental new drug application (sNDA) for expansion of Vascepa® (icosapent ethyl) labeling based on the REDUCE-IT™ cardiovascular outcomes study. Before this communication, the FDA had been silent as to whether it would convene an AdCom in connection with its review of the REDUCE-IT sNDA. The FDA expressed, based on the timing of its recent decision to convene an AdCom, that November 14th is the earliest date on which it could hold an AdCom due t
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- VASCEPA® (Icosapent Ethyl) Found to Significantly Reduce Cardiovascular Events in Patients with Compromised Renal Function at Baseline in Prespecified and Post Hoc Subgroup Analyses of Landmark REDUCE-IT® Study Presented at American Society of Nephrology GlobeNewswire
- U.S. Veterans with Decreased Renal Function Shown to Be at Higher Risk for Adverse Cardiovascular Events if They Have Moderately Elevated Triglyceride (TG) Levels Despite Well-Controlled Low-Density Lipoprotein (LDL)-CholesterolGlobeNewswire
- Amarin to Report Third Quarter 2020 Results and Host Conference Call on November 5, 2020GlobeNewswire
- VASCEPA® (Icosapent Ethyl) Found to Significantly Reduce Ischemic Events in Patients with Prior Percutaneous Coronary Intervention (PCI) in Post Hoc Subgroup Analyses of Landmark REDUCE-IT® Study Presented at Transcatheter Cardiovascular Therapeutics (TCTGlobeNewswire
- Thinking about buying stock in Ion Geophysical, TPI Composites, Coty, Tilray, or Amarin Corp?PR Newswire
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AMRN
SEC Filings
- 10/22/20 - Form 4
- 10/2/20 - Form 4
- 10/2/20 - Form 4
- AMRN's page on the SEC website
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