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3612 Articles Matching "fda"

U.S. FDA labels J&J surgical staplers' recall as severest

May 18, 2019 , Reuters
The U.S. Food and Drug Administration warned of risks of serious injury or death from surgical staplers made by Johnson & Johnson's Ethicon unit, labeling a recent recall of the device as its most serious....
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Zydus Cadila’s generic Thalitone gets FDA OK

May 18, 2019 , Drug Store News - Retail
Zydus Cadila's chlorthalidone tablets will be available in two dosage strengths. Read More...
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Alembic receives FDA nod for generic Pataday

May 17, 2019 , Drug Store News - Retail
Olopatadine hydrochloride ophthalmic solution, 0.2%, had a market value of $62 million for the 12 months ending December 2018, according to IQVIA data. Read More...
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FDA issues guidance on interchangeable biosimilars

May 17, 2019 , Drug Store News - Retail
The Food and Drug Administration is providing final guidance on the pathway for “interchangeable” biologics, which may be substituted without the involvement of the prescriber. Read More...
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Ruling turns up pressure for FDA to strictly regulate e-cigarettes

May 17, 2019 , CNN Health
Some politicians and pediatricians have urged the US Food and Drug Administration to take strong, swift action on the growing use of e-cigarettes among America's youth, but the latest move comes from a federal judge who ordered the agency to speed up its review of thousands of vaping products now on the market....
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Demo

Roche: FDA approves drug combo Venclexta plus Gazyva for previously untreated chronic lymphocytic leukemia

May 17, 2019 , Reuters
Roche said on Thursday that the U.S. Food and Drug Administration had approved a treatment using its drugs Venclexta plus Gazyva for people with previously untreated chronic lymphocytic leukemia....
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FDA can't regulate death penalty drugs, Justice Department says

May 16, 2019 , CNN Health
The Food and Drug Administration does not have jurisdiction over death penalty drugs, the Justice Department said in an opinion....
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Tattoo Inks Recalled Over Bacterial Contamination

May 16, 2019 , WebMD
Consumers should ask their tattoo artist or studio about the inks they use and avoid the recalled inks, the FDA...
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FDA clears AI that detects ‘ticking time bomb’ in chest images

May 16, 2019 dave.muoio@himssmedia.com (Dave Muoio), Mobile Health News
AIdoc's tool flags potential cases of pulmonary embolism to ensure prompt review and...
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Majority of sunscreens tested would flunk proposed FDA safety tests, report says

May 16, 2019 , CNN Health
Nearly two-thirds of all sunscreens evaluated by the Environmental Working Group would not pass safety tests proposed by the US Food and Drug Administration, the consumer advocacy group announced Wednesday....
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FDA clears AI tool to help radiologists spot pneumothorax

May 15, 2019 dave.muoio@himssmedia.com (Dave Muoio), Mobile Health News
Zebra Medical Vision's tool interprets medical imaging and flags potential cases for specialist...
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A demo

FDA advisory panel votes against Daiichi Sankyo's blood cancer treatment

May 15, 2019 , Reuters
Independent experts on an advisory panel to the U.S. Food and Drug Administration on Tuesday voted against Daiichi Sankyo Co Ltd's treatment for adults with a type of acute myeloid leukemia....
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Amerigen’s generic Cuprimine gets FDA OK

May 15, 2019 , Drug Store News - Retail
The Food and Drug Administration approved Cuprimine's penicillamine capsules. Read More...
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Israel's Zebra Medical gets FDA ok for AI chest X-ray product

May 14, 2019 , Reuters
Israel's Zebra Medical Vision said on Monday it received approval from the U.S. Food and Drug Administration for its artificial intelligence-based chest X-ray triage product....
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Phillip Morris halts global campaign featuring young influencers

May 14, 2019 , Healthcare Comm.
The depiction of an under-25 user of a vaporizer product ‘was a clear breach’ of its own policy, the company says, emphasizing that no laws were broken. Still, the FDA is keeping watch. Where there’s smoke—or vapor—there’s a potential PR firestorm. Phillip Morris International has stopped a global social media campaign after reporters discovered the […] The post Phillip Morris halts global campaign featuring young influencers appeared first on Health Care Communication...
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FDA clears AliveCor's six-lead smartphone ECG

May 14, 2019 dave.muoio@himssmedia.com (Dave Muoio), Mobile Health News
The KardiaMobile 6L builds upon its predecessor with a third electrode placed on its back side, allowing cardiologists better insight into device owners'...
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Motus Nova Expands FDA-Approved Robotic Stroke Therapy System, Adds New Hospital Partners

May 13, 2019 , NewsLine - Healthcare Professionals
Motus Nova, a technology firm offering the only robotic system approved by the FDA to be as effective as an in-person therapist for remote stroke rehabilitation, announced today that it is expanding its list of partner hospitals and clinics using the device, as well as making plans to introduce its ......
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AAM, Biosimilars Council oppose FDA biosimilar naming update

May 09, 2019 , Drug Store News - Retail
The Association for Accessible Medicines said the Food and Drug Administration's guidance on naming biological products delays the development of biosimilars. Read More...
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FDA undercuts $375,000 drug in surprise move

May 09, 2019 , CNN Health
The US Food and Drug Administration created a workaround this week that effectively undercuts the $375,000 price tag of a drug that became the poster child for concerns about the pharmaceutical industry....
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Walmart raises minimum age to buy tobacco to 21 as pressure mounts to curb illegal sales to minors

May 09, 2019 , CNBC Health
Walmart outlined steps to prevent minors from buying tobacco products in a letter to the...
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