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Advisers to the U.S. Food and Drug Administration on Tuesday backed an approval for Abbott Laboratories' heart valve repair device that is designed for patients who are at risk of complications or ...
By Puyaan Singh (Reuters) -Abbott Laboratories said on Tuesday the U.S. FDA has approved its heart valve repair device for patients with a potentially fatal heart disease, just months after rival ...
Conducted at 31 medical centers in the U.S., Canada and Europe, the study followed 1,014 eligible patients implanted with the Trifecta valve between 2007 and 2009 as part of a U.S. Food and Drug ...
The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012.It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics.
Control of the Senate, Presidency, and House since 1855: any column where all three sections show the same color is a trifecta.. The term is primarily used in the United States, where the federal government level consists of the president and the Congress with its two chambers, the House and the Senate.
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In January, the FDA asked a host of drugmakers including Gilead Sciences, Johnson & Johnson and Novartis to add a boxed warning to their CAR-T cancer therapies, as it received reports of patients ...
(Reuters) -The U.S. Food and Drug Administration has approved Ionis Pharmaceuticals' drug to treat a rare genetic disorder, making it the company's first wholly-owned drug, the health regulator's ...