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Sanofi and Regeneron Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) approved Praluent® (alirocumab) Injection, the first FDA-approved treatment in a new class of drugs known as PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors. Praluent is indicated…

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The U.S. Food and Drug Administration approved Kengreal (cangrelor), an intravenous antiplatelet drug that prevents formation of harmful blood clots in the coronary arteries, the blood vessels that supply blood to the heart. It is approved for adult patients undergoing…


Exoskeleton leader ReWalk Robotics announced that the U.S. Food and Drug Administration has cleared the company’s ReWalk Personal System for use at home and in the community. ReWalk is a wearable robotic exoskeleton that provides powered hip and…


The Food and Drug Administration, USA has ordered 23andme – the maker of a popular genetic-testing kit to stop sales of its heavily marketed product, saying the mail-order tests haven’t been proven effective and could dangerously mislead people about…


US FDA is taking two actions to further enhance the agency’s ongoing efforts to prevent and resolve drug shortages, a significant public health threat that can delay, and in some cases even deny, critical care for patients. Following…


The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, took action this week against more than 4,100 Internet pharmacies that illegally sell potentially dangerous, unapproved drugs to consumers. Actions taken include civil and…


The U.S. Food and Drug Administration approved Zaltrap (ziv-aflibercept) for use in combination with a FOLFIRI (folinic acid, fluorouracil and irinotecan) chemotherapy regimen to treat adults with colorectal cancer. Zaltrap is an angiogenesis inhibitor that inhibits the blood…


The Oncologic Drugs Advisory Committee, FDA, USA disapproved the Avastin which cited a lack of survival benefit. Now as two more trials have been analyzed — neither showing a survival benefit — the FDA stated that in the balance,…


The U.S. Food and Drug Administration (FDA) is reviewing data, submitted in August 2009, from a large, long-term clinical study on possible risks with the diabetes drug, Avandia (rosiglitazone). The clinical study, called the Rosiglitazone Evaluated for Cardiovascular…


Most Americans support for measures that would give the Food and Drug Administration (FDA) new authority to ensure the food Americans eat does not make them sick. The poll survey was conducted in selected states of US ?…

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