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, each representing one Ordinary Share (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
- After Plunging -19.13% in 4 Weeks, Here's Why the Trend Might Reverse for Amarin (AMRN) [Yahoo! Finance]Yahoo! Finance
- Investigators to Present New REDUCE-IT Subanalysis of VASCEPA®/VAZKEPA® (icosapent ethyl) in Patients With and Without Coronary Artery Disease History and Mechanistic Data on Eicosapentaenoic Acid (EPA) at the American Heart Association’s (AHA) Annual SciGlobeNewswire
- Amarin Reports Third Quarter 2024 Financial Results and Provides Business UpdateGlobeNewswire
- Amarin Announces Two Upcoming Investor EventsGlobeNewswire
- Prilenia Appoints Rob Lauzen as Chief Financial Officer and Jason Marks as Chief Legal OfficerBusiness Wire
AMRN
Earnings
- 10/30/24 - Beat
AMRN
Sec Filings
- 10/31/24 - Form 3
- 10/30/24 - Form 10-Q
- 10/30/24 - Form 8-K
- AMRN's page on the SEC website