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PMLiVE 11/15/2019 05:50
The Endocrinologic and Metabolic Drugs Advisory Committee of the FDA voted 16-0 to recommend the expansion of Vascepa (icosapent ethyl) to reduce the risk of cardiovascular events, such as heart attacks and stroke, in high-risk patients.
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GlobeNewswire 11/14/2019 17:34
The FDA has not reviewed the information herein or determined whether to approve Vascepa for use to reduce the risk of major adverse cardiovascular events as studied in REDUCE-IT.
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PR Newswire 11/04/2019 07:00
The proposed indication to be discussed at this upcoming CRDAC meeting is for the rapid conversion of recent onset atrial fibrillation (AF) to sinus rhythm in adult patients.
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Business Wire 10/26/2019 09:15
The FDA’s letters to health care providers earlier this year have helped Abiomed and the post-approval study principal investigators educate other medical providers on the importance of using simple identifiers to achieve timely identification of right side heart failure in the catheterization lab and ICU,” said Seth Bilazarian, MD, the chief medical officer of Abiomed ...
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Cardiac Rhythm News 10/22/2019 11:19
The US Food and Drug Administration (FDA) has approved Farxiga (dapaglifozin, AstraZeneca) to reduce the risk of hospitalisation for heart failure in adults with type 2 diabetes and established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.
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AstraZeneca has secured approval from the US Food and Drug Administration (FDA) for its Farxiga (dapagliflozin) to reduce the risk of hospitalisation for heart failure (hHF) in adults with type-2 diabetes (T2D) and established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors ...
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Healio News 10/21/2019 10:03
In DAPA-HF, dapagliflozin added to standard therapy for heart failure was associated with reduced risk for worsening heart failure and CV death for patients with heart failure with and without diabetes.
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ENDPOINTS 10/21/2019 08:55
The results showed that the Farxiga treatment did trigger a lower rate of hospitalization for heart failure — but the therapy was not better or worse than placebo in its impact on the rate of major adverse cardiovascular events (MACE), defined as cardiovascular death, myocardial infarction, or ischemic stroke.
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Drugs.com 10/20/2019 22:10
This is promising news for the 30 million people living with type 2 diabetes in the US, as heart failure is one of the earliest cardiovascular complications for them, before heart attack or stroke.
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