3191 Articles Matching "fda"
Verily's research wearable lands FDA clearance for on-demand ECG
Jan 19, 2019The Verily Study Watch is a prescription-only wearable that can record, store, transfer and display single-channel ECG...
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FDA chief: Agency has money for about 5 more weeks of drug approvals
Jan 19, 2019
FDA commissioner Scott Gottlieb responded to queries about the government shutdown's effect on drug approvals on Twitter.
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FDA looking how to get nicotine-addicted teens to quit vaping as e-cigarette 'epidemic' grinds on
Jan 19, 2019The FDA says doctors need more information about treating kids for nicotine use since most cessation products are only for...
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FDA approves new Cabometyx indication
Jan 19, 2019
FDA's approval of a new Cabometyx indication provides a treatment for patients with liver cancer.
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Samsung Bioepis biosimilar to Roche's Herceptin wins FDA nod
Jan 19, 2019The U.S. Food and Drug Administration said on Friday it had approved a biosimilar to Roche Holding AG's blockbuster breast cancer treatment, Herceptin....
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FDA clears the way to increase access and lower cost of life-saving opioid overdose treatment drug
Jan 18, 2019The FDA's change clears the way for drugmakers to sell naloxone without a prescription. The life-saving treatment for opioids is also known as Narcan and...
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FDA Clears Epilepsy Smartwatch for Use in Kids
Jan 18, 2019Title: FDA Clears Epilepsy Smartwatch for Use in KidsCategory: Health NewsCreated: 1/16/2019 12:00:00 AMLast Editorial Review: 1/16/2019 12:00:00...
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Nexus Pharmaceuticals gets FDA OK for generic Busulfex injection
Jan 18, 2019
Nexus Pharmaceuticals' generic Busulfex is the company's second oncology generic drug.
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FDA advisory panel split over Sanofi-Lexicon diabetes drug
Jan 18, 2019An advisory panel to the U.S. Food and Drug Administration was divided over whether to recommend approval of a treatment for type 1 diabetes developed by Lexicon Pharmaceuticals Inc and France's Sanofi SA....
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Vitruvius Therapeutics gets FDA nod for vitamin B-12 injection
Jan 18, 2019
Vitruvius Therapeutics has received the FDA's blessing for its vitamin B-12 injection, which had a market value of roughly $74.3 million for the year ended September 2018.
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Immunomedics' cancer treatment fails to win accelerated approval from the FDA
Jan 18, 2019Immunomedics Inc said on Thursday the U.S. Food and Drug Administration declined to grant accelerated approval for its breast cancer treatment, sacituzumab....
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FDA gets closer to making naloxone available over the counter
Jan 18, 2019The Food and Drug Administration is preparing to allow the over-the-counter purchase of the drug overdose-reversal medication naloxone in an effort to expand greater access to the lifesaving...
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Teva gets FDA green light for generic Sabril
Jan 17, 2019
Teva has received the Food and Drug Administration's approval for the first generic of Lundbeck's Sabril.
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Amgen's postmenopausal osteoporosis drug wins FDA panel backing
Jan 17, 2019An advisory panel to the U.S. Food and Drug Administration said on Wednesday that benefits of Amgen Inc's osteoporosis treatment for postmenopausal women at high risk for fracture outweighed its risks and overwhelmingly voted for the drug's approval....
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U.S. shutdown taking toll on FDA, USDA inspection roles: experts
Jan 17, 2019The partial government shutdown is taking a toll on key safety inspection duties performed by the U.S. Food and Drug Administration and Department of Agriculture, food safety experts said on Wednesday....
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The FDA has five weeks till money runs out for approving new drugs
Jan 17, 2019The US Food and Drug Administration has roughly five weeks of funding left to review new drug applications during the shutdown, commissioner Dr. Scott Gottlieb said Monday on Twitter....
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FDA to Resume Inspections of Riskier Foods
Jan 17, 2019Title: FDA to Resume Inspections of Riskier FoodsCategory: Health NewsCreated: 1/15/2019 12:00:00 AMLast Editorial Review: 1/15/2019 12:00:00...
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FDA Clears Epilepsy Smartwatch for Use in Kids
Jan 16, 2019The Embrace detects patterns in motion and physiological signals that may be associated with seizures, and immediately alerts...
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Amneal gets FDA nod for generic Exelon patch
Jan 16, 2019
The FDA has approved Amneal's generic Exelon patch, which had a market value of roughly $225 million.
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FDA approves expanded use of Adacel vaccine
Jan 16, 2019
Adacel is now the first and only Tdap vaccine in the United States approved for a repeat dose in people between the ages of 10-to-64 years old, administered eight or more years after the first vaccination.
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