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3192 Articles Matching "fda"

FDA Panel Splits Vote on New Diabetes Drug

Jan 20, 2019 , MedicineNet
Title: FDA Panel Splits Vote on New Diabetes DrugCategory: Health NewsCreated: 1/17/2019 12:00:00 AMLast Editorial Review: 1/18/2019 12:00:00...
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Verily's research wearable lands FDA clearance for on-demand ECG

Jan 19, 2019 laura.lovett@himssmedia.com (Laura Lovett), Mobile Health News
The 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 , Drug Store News - Retail
FDA commissioner Scott Gottlieb responded to queries about the government shutdown's effect on drug approvals on Twitter. Read More...
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FDA looking how to get nicotine-addicted teens to quit vaping as e-cigarette 'epidemic' grinds on

Jan 19, 2019 , CNBC Health
The 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 , Drug Store News - Retail
FDA's approval of a new Cabometyx indication provides a treatment for patients with liver cancer. Read More...
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Samsung Bioepis biosimilar to Roche's Herceptin wins FDA nod

Jan 19, 2019 , Reuters
The 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, 2019 , CNBC Health
The 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, 2019 , MedicineNet
Title: 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 , Drug Store News - Retail
Nexus Pharmaceuticals' generic Busulfex is the company's second oncology generic drug. Read More...
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FDA advisory panel split over Sanofi-Lexicon diabetes drug

Jan 18, 2019 , Reuters
An 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 , Drug Store News - Retail
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. Read More...
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Immunomedics' cancer treatment fails to win accelerated approval from the FDA

Jan 18, 2019 , Reuters
Immunomedics 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, 2019 , Modern Healthcare Breaking News
The 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 , Drug Store News - Retail
Teva has received the Food and Drug Administration's approval for the first generic of Lundbeck's Sabril. Read More...
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Amgen's postmenopausal osteoporosis drug wins FDA panel backing

Jan 17, 2019 , Reuters
An 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, 2019 , Reuters
The 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, 2019 , CNN Health
The 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, 2019 , MedicineNet
Title: 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, 2019 , WebMD
The 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 , Drug Store News - Retail
The FDA has approved Amneal's generic Exelon patch, which had a market value of roughly $225 million. Read More...
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