Amarin Announced FDA Advisory Committee Voted Unanimously (16-0) to Recommend Approval of Vascepa® (icosapent ethyl) Capsules Label Expansion to Reduce Cardiovascular Risk Based on Landmar...
Amarin Corporation plc - American Depositary Shares (AMRN)
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Source: GlobeNewswire
Cardiovascular disease events like heart attacks, stroke and death affect millions of patients in the United States and are estimated to cost $500 billion annuallyMillions of high-risk patients with cardiovascular disease could benefit from this cost-effective therapy if expanded label receives FDA approval; PDUFA date is December 28 DUBLIN, Ireland and BRIDGEWATER, N.J., Nov. 14, 2019 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ: AMRN) today announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the U.S. Food and Drug Administration (FDA) has voted unanimously (16-0) to recommend approval of an indication and label expansion for Vascepa® (icosapent ethyl) capsules to reduce the risk of cardiovascular events in high-risk patients based on results from the landmark REDUCE-IT®1 cardiovascular outcomes trial. The FDA is not bound by the recommendations of an advisory committee. Amarin plans to work with the agency as it completes its review of the c
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News
- New REDUCE-IT® Aspirin Analysis Presented at AHA Scientific Sessions 2025 Reinforces VASCEPA®/VAZKEPA® (Icosapent Ethyl) Reduced Cardiovascular Events in High-Risk PatientsGlobeNewswire
- Amarin To Present New Analyses Affirming Robustness of Data from REDUCE-IT and Additional Mechanisms of Action of Eicosapentaenoic Acid (EPA) at American Heart Association (AHA) Scientific Sessions 2025GlobeNewswire
- Amarin (NASDAQ:AMRN) was upgraded by analysts at <a style="font-weight:bold" href="https://www.wallstreetzen.com/newsletters/zen-ratings?ticker=AMRN&utm_campaign=getratings&utm_medium=online&utm_source=MarketBeat">Wall Street Zen</a> froMarketBeat
- Amarin Reports Third Quarter 2025 Financial ResultsGlobeNewswire
- Amarin Issues Statement Supporting FDA’s Action to Revise Labeling for Fenofibrate Drugs Reinforcing a Lack of Cardiovascular BenefitGlobeNewswire
AMRN
Earnings
- 10/29/25 - Beat
AMRN
Sec Filings
- 10/31/25 - Form 3
- 10/29/25 - Form 10-Q
- 10/29/25 - Form 8-K
- AMRN's page on the SEC website