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3935 Articles Matching "fda"

FDA approves Clinuvel's rare genetic disorder treatment, shares at record high

Oct 09, 2019 , Reuters
The U.S. Food and Drug Administration approved Australian drugmaker Clinuvel Pharmaceuticals Ltd's treatment for a rare inherited disorder that causes skin damage from exposure to light, sending its shares to a record high on Wednesday....
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Dexcom G6 Pro CGM gets FDA nod

Oct 09, 2019 laura.lovett@himssmedia.com (Laura Lovett), Mobile Health News
The technology includes one-time use sensors and can switch between blind and unblinded...
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FDA warns consumers to stop using THC vaping products

Oct 07, 2019 , CNN Health
The US Food and Drug Administration is warning consumers to stop using THC vaping products as investigations into vaping-related lung injuries and deaths continue....
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FDA green lights AstraZeneca's asthma drug Fasenra for self-administration

Oct 05, 2019 , Reuters
British drugmaker AstraZeneca said on Friday that the U.S. Food and Drug Administration (FDA) has approved self-administration of its asthma treatment Fasenra which uses a pre-filled, single-use auto-injector pen....
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Pacemakers, Insulin Pumps Could Be Hacking Targets: FDA

Oct 04, 2019 , WebMD
This warning concerns several operating systems that could affect medical devices connected to a network like Wi-Fi and public or home internet, and equipment such as routers, phones and other communications gear, the agency...
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U.S. FDA approves Gilead's Descovy for HIV prevention

Oct 04, 2019 , Reuters
The U.S. Food and Drug Administration on Thursday approved Gilead Sciences Inc's Descovy to reduce the risk of sexually acquired HIV infection in men and transgender women who have sex with men....
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FDA Asks Drugmakers To Conduct Their Own Tests Of Heartburn Drug Zantac For Carcinogen, While Walmart Joins In Pulling Drug From Shelves

Oct 04, 2019 , Kaiser Health News
The FDA is challenging how the test was conducted that showed unsafe levels of a carcinogen, but in the meantime, Walmart has joined other major drug retailers no longer selling the...
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Pacemakers, Insulin Pumps Could Be Hacking Targets: FDA

Oct 03, 2019 , MedicineNet
Title: Pacemakers, Insulin Pumps Could Be Hacking Targets: FDACategory: Health NewsCreated: 10/1/2019 12:00:00 AMLast Editorial Review: 10/2/2019 12:00:00...
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FDA says finds 'unacceptable level' of carcinogen in Zantac and its generics

Oct 03, 2019 , Reuters
The U.S. Food and Drug Administration said on Wednesday it found "unacceptable levels" of a cancer-causing impurity in the popular heartburn drug Zantac and its generic versions known chemically as ranitidine....
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Ex-FDA Head Robert Califf Hired To Lead Strategy At Google Health, Verily Life Sciences

Oct 02, 2019 , Kaiser Health News
Former Food and Drug Administration Commissioner Dr. Robert Califf has been tapped by Google parent Alphabet to serve as head of strategy and policy for Google Health and Verily Life Sciences. Califf served at FDA from 2016 to 2017 during the Obama administration. And other hospital and health system news is reported from Massachusetts, New Hampshire and...
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Pharmacy Chains CVS, Walgreens, Rite Aid Remove Zantac From Store Shelves Over Cancer Concerns

Oct 02, 2019 , Kaiser Health News
The FDA is investigating the source of the contamination in the popular heartburn...
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Cardon Children's Medical Center

Roche's Accu-Chek recalled for sixth time, Alphabet scoops former FDA commissioner, and other digital health news briefs

Oct 02, 2019 dave.muoio@himssmedia.com (Dave Muoio), Mobile Health News
Also: ResApp announces results of prospective study on obstructive sleep apnea; Cosnumer telemedicine company Hims opens pharmacy operation in Columbus,...
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FDA issues warning on medical devices that are vulnerable to takeover from hackers

Oct 02, 2019 , CNBC Health
The FDA said it's not sure how many or even which specific medical devices, such as insulin pumps or pacemakers, are vulnerable to getting...
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The FDA Tried To Ban Kid-Friendly, Flavored Vaping Fluids Years Ago – What Stopped It?

Oct 02, 2019 , Kaiser Health News
The Los Angeles Times reports that as the regulation was being considered as part of an Obama administration tobacco control rule, tobacco industry lobbyists and small business advocates applied a full court press on the White House. Now, with so much attention on the vaping disease outbreak, some congressional Republicans are being pulled between free market principles and efforts to regulate e-cigarette and vaping products. Outlets also report on the sprawling black market for vaping...
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Raw Dog Food May Pose Salmonella Threat

Oct 01, 2019 , WebMD
The FDA is warning people not to give dogs frozen Performance Dog Raw Pet Food because it has tested positive for Salmonella and Listeria...
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Second Generic Zantac Recall Due to Contamination Concerns

Oct 01, 2019 , RxList
In the wake of other recent recalls of over-the-counter generic Zantac (ranitidine), Apotex Corp has voluntarily recalled all pack sizes and formats of ranitidine tablets (75 and 150 mg) on a "precautionary basis," according to a company statement posted on the US Food and Drug Administration (FDA)...
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Alphabet taps former FDA commissioner to oversee health strategy and policy

Oct 01, 2019 , CNBC Health
Alphabet has tapped former FDA commissioner Robert Califf as it grows its health...
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Walgreens joins CVS in suspending sales of heartburn medicine Zantac during safety review

Oct 01, 2019 , CNBC Health
Walgreens is the latest retailer to suspend sales of Sanofi's heartburn medication Zantac and other generic ranitidine products while the FDA reviews their...
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Ex-FDA chief McClellan says 'structures' weren't in place to identify vaping crisis earlier

Oct 01, 2019 , CNBC Health
McClellan says former FDA chief Scott Gottlieb had tried over the last couple of years to put a more "aggressive regulatory structure in place" for use of...
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FDA issues warning letters to websites selling illegal opioids

Oct 01, 2019 , Reuters
The U.S. Food and Drug Administration and the Drug Enforcement Administration (DEA) jointly issued warning letters to four online networks for illegally marketing unapproved and misbranded versions of opioid medicines, the agencies said....
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