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2204 Articles Matching "fda"

KemPharm's opioid painkiller gets FDA approval, shares soar

Feb 24, 2018 , Reuters
(Reuters) - KemPharm Inc said on Friday the U.S. Food and Drug Administration approved its opioid painkiller Apadaz for the short-term management of acute pain, sending the shares of the drugmaker up as much as 36 percent in late afternoon trading....
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FDA recognizes Cognoa's child development app as autism diagnostic

Feb 23, 2018 dave.muoio@himssmedia.com (Dave Muoio), Mobile Health News
Palo Alto, California-based Cognoa’s machine learning app for pediatric behavioral health has received categorization from the FDA as a Class 2 diagnostic medical device for autism, according to an announcement from the...
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FDA Cracks Down on Kratom Products

Feb 23, 2018 , MedicineNet
Title: FDA Cracks Down on Kratom ProductsCategory: Health NewsCreated: 2/21/2018 12:00:00 AMLast Editorial Review: 2/22/2018 12:00:00...
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FDA Cracks Down on Kratom Products

Feb 22, 2018 , WebMD
Kratom -- a plant that grows in Asia -- poses serious health risks, according to the FDA. Earlier this month, the agency declared that kratom acts like an opioid in the human...
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Koch-backed risky drug law now in 38 states. Trump wants to take it national, but resistance grows.

Feb 22, 2018 , CNBC Health
"Right to Try" would allow patients to skip the FDA in finding treatments. Many feel this would hurt vulnerable...
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U.S. FDA says recalls, destroys certain kratom-containing dietary products

Feb 22, 2018 , Reuters
(Reuters) - The U.S. Food and Drug Administration on Wednesday said it recalled and destroyed a large volume of kratom-containing dietary supplements made by a company in Missouri....
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Roche’s Accu-Chek diabetes management app receives its fifth FDA recall

Feb 21, 2018 dave.muoio@himssmedia.com (Dave Muoio), Mobile Health News
Roche’s Accu-Chek Connect Diabetes Management App has hit yet another snag with the FDA. On February 15, the agency issued a Class 2 Device Recall for certain software versions of the app due to a bug that could lead users to self-administer inappropriate doses of...
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Is Alzheimer’s A Glitch Of Our Brain’s Ancient Immune System?

Feb 21, 2018 , Kaiser Health News
Connecting Alzheimer's and the immune system was a radical idea at first but these scientists pushed on. In other news, FDA has opened the doors to drugs that would treat people who have biomarkers of a disease but aren't yet showing symptoms....
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MemoryMD gets FDA clearance for wireless EEG amplifier

Feb 21, 2018 jonah.comstock@mobihealthnews.com (Jonah Comstock), Mobile Health News
New York and Palo Alto, California-based MemoryMD has received FDA clearance for NeuroEEG, a wireless amplifier that transmits EEG signals to computers and cloud-based databases via Bluetooth. The other half of MemoryMD's offering, a disposable EEG cap called NeuroCap, is still awaiting...
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Potentially Lethal Drug Found In Popular Dog Food Brands: What You Need To Know

Feb 20, 2018 , Forbes
Pentobarbital, a powerful and potentially deadly sedative, has been found in small quantities in multiple dog food brands manufactured by the J.M. Smucker Company, according to a FDA news release earlier...
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U.S. FDA approves AstraZeneca's immunotherapy for lung cancer

Feb 17, 2018 , Reuters
(Reuters) - The U.S. Food and Drug Administration on Friday granted approval for expanded use of AstraZeneca Plc's, immunotherapy drug, Imfinzi, to treat non-small cell lung cancer whose tumors can't be surgically removed....
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Shares of Apricus tank after FDA declines to OK erectile dysfunction cream

Feb 17, 2018 , Reuters
(Reuters) - The U.S. Food and Drug Administration on Friday declined to approve Apricus Biosciences Inc's Vitaros, a cream to treat erectile dysfunction, for the second time in a decade, sending the company's shares down more than 70 percent before the opening bell....
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FDA Warning: Euthanasia Drug Found in Wet Dog Food

Feb 17, 2018 , WebMD
J.M. Smucker Co. said it has pulled specific shipments of Gravy Train, Kibbles 'N Bits, Ol’ Roy, and Skippy canned wet dog...
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U.S. FDA looks to pave way for earlier-stage Alzheimer's drugs

Feb 16, 2018 , Reuters
(Reuters) - U.S. regulators have proposed lowering the bar for clinical trial success for experimental Alzheimer's drugs to better align with the current emphasis on the need to treat people when they are in the earliest stages of the brain-wasting disease....
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Blood Test For Concussions Approved By FDA For First Time

Feb 16, 2018 , Kaiser Health News
Currently, most patients with suspected traumatic brain injury are evaluated using a neurological exam, followed by a CT scan. FDA Commissioner Scott Gottlieb said that the blood test could save the health care system money by preventing unnecessary...
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FDA Head Vows To Tackle High Drug Prices And Drugmakers ‘Gaming The System’

Feb 16, 2018 , Kaiser Health News
In an exclusive interview, FDA Commissioner Scott Gottlieb describes what he’s doing to spur competition and bring down drug...
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FDA Clears First Blood Test for Concussion

Feb 16, 2018 , eMedicine Health
FDA Clears First Blood Test to Aid in Concussion...
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Podcast: KHN’s ‘What The Health?’ What Do The Budget, Idaho And FDA Chief Scott Gottlieb Have In Common?

Feb 16, 2018 , Kaiser Health News
In this episode of KHN’s “What the Health?” Julie Rovner of Kaiser Health News, Margot Sanger-Katz of The New York Times, Stephanie Armour of The Wall Street Journal and Paige Winfield-Cunningham of The Washington Post discuss President Donald Trump’s budget plan and how some states are trying to stabilize the Affordable Care Act, while others are trying to violate it. Also, Rovner and KHN’s Sarah Jane Tribble interview Scott Gottlieb, commissioner of the Food and Drug Administration....
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FDA Approves First Blood Test to Detect Concussion

Feb 16, 2018 , WebMD
Known as the Banyan Brain Trauma Indicator, it could help reduce the need for CT scans and thus decrease radiation exposure to patients, according to the...
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FDA budget requests include clinical software, natural language processing, real-time device data

Feb 16, 2018 , Mobile Health News
Food and Drug Administration Commissioner Dr. Scott Gottlieb released the agency’s budget requests for fiscal 2018 Tuesday, outlining digital health plans for the...
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