Posts filtered by tags: Fda[x]


 

Alphabet’s Verily Study Watch gets FDA approval for ECG feature

Verily has announced a health watch in 2017 that is aimed at offering insights into medical conditions such as Parkinson's disease and PTSD. Now, Verily has received FDA clearance for the watch's electrocardiogram (ECG) technology. Verily says the watch can record and display single-channel ECG rhythms. Along with the research trials. Doctors can also prescribe the device to individuals as part of their clinical care. Now that Verily has earned FDA approval, it wouldn't be surprising if Goog...
Tags: Apple, Google, News, Blogging, Smartwatches, Fda, Verily, U S Food and Drug Administration FDA, Study Watch


FDA head: Agency may call back more food safety staff, currently out due to shutdown

Food and Drug Administration head Scott Gottlieb says the agency may call back additional unpaid food safety workers during the government shutdown.            [Author: USA TODAY]
Tags: Usa, News, Fda, Usa Today, Scott Gottlieb, Drug Administration


E-Cigs Like Juul Face 'Existential Threat' Over Teen Smoking, FDA Says

The Food and Drug Administration (FDA) is continuing to increase pressure on tobacco and e-cigarette makers to take significant measures to keep their products out of the hands of teens, with the agency indicating that Juul in particular needs to make good on its commitments to doing so. Now, FDA Commissioner Scott…Read more...
Tags: Science, Smoking, Fda, E Cigarettes, Teen Smoking, Juul, Scott, Food and Drug Administration FDA, Juuling


E-cigarettes could be banned in US, FDA says

E-cigarettes and vaping products face an "existential threat" in the US if their use among young people continues to rise, the commissioner of the Food and Drug Administration (FDA) has warned. Scott Gottlieb spoke on Friday at a public hearing in Maryland focused on eliminating the use of "electronic cigarette and other tobacco product use" among American youth, at a time when the agency has threatened stores selling e-cigarettes to minors and seized thousands of documents from Juul Labs, the ...
Tags: News, Maryland, US, Fda, Food and Drug Administration FDA, Gottlieb, Scott Gottlieb, Juul Labs


Alphabet’s health watch monitors your heart health, is approved by the FDA

A health monitoring watch being developed by Alphabet, Google's parent company, has received clearance from the FDA as a medical device. This means that the device has been found to be safe and can legally be sold in the U.S. The post Alphabet’s health watch monitors your heart health, is approved by the FDA appeared first on Digital Trends.
Tags: Health, Wearables, News, Trends, Fda, Alphabet, Verily, Alphabet Google, Heart Monitoring


Interview: How Men’s Healthcare Startup hims Enables Convenient And Affordable Treatment

hims is an online-only personal care brand that combines low costs with FDA-approved and doctor-backed products that empower consumers to take care of their health from the privacy of their home
Tags: Trends, Fda, Healthcare Startup


FDA Panel Splits Vote on New Diabetes Drug

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 AM
Tags: Fda


Samsung Bioepis biosimilar to Roche's Herceptin wins FDA nod

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. The biosimilar, Ontruzant, is sold by Merck Sharp & Dohme Corp, a unit of Merck & Co Inc, and is developed by Samsung Bioepis Co Ltd, which is a joint venture between Samsung BioLogics and Biogen Inc. The approval https://twitter.com/FDA_Drug_Info/status/1086327386059157504 comes just a few weeks after the health regulator gave Celltrion Inc's ...
Tags: Science, Samsung, Fda, U S Food and Drug Administration, Roche, Merck Co Inc, Biogen Inc, Samsung BioLogics, Roche Holding AG, Celltrion Inc, Samsung Bioepis Co Ltd, Merck Sharp Dohme Corp, Herzuma


Samsung Bioepis-Merck biosimilar to Roche's Herceptin wins FDA nod

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. The biosimilar, Ontruzant, is co-developed by Merck Sharp & Dohme Corp, a unit of Merck & Co Inc, and Samsung Bioepis Co Ltd, which is a joint venture between Samsung BioLogics and Biogen Inc. The approval https://twitter.com/FDA_Drug_Info/status/1086327386059157504 comes just a few weeks after the health regulator gave Celltrion Inc's Herzuma ...
Tags: Science, Samsung, Fda, U S Food and Drug Administration, Roche, Merck Co Inc, Biogen Inc, Samsung BioLogics, Roche Holding AG, Celltrion Inc, Samsung Bioepis Co Ltd, Merck Sharp Dohme Corp, Herzuma


Alphabet’s Verily scores FDA clearance for its ECG monitor

Big week for Google wearable news — which, honestly, is not a phrase I expected to write in 2019. But a day after the company announced an agreement to purchase Fossil’s wearable technology for $40 million, Alphabet-owned research group Verily just scored FDA clearance for its electrocardiogram (ECG) technology. The clearance pertains specifically to the company’s Study Watch. The device, which was announced back in 2017, shouldn’t be confused with the company’s more consumer-facing Wear OS ...
Tags: Apple, Health, Google, Wearables, Tech, Fda, Verily


The FDA is considering drugs to help kids quit vaping

The US Food and Drug Administration is considering the role of drug therapies to get kids to quit vapes and other nicotine products, with medical organizations and vaping groups weighing in during a public hearing Friday on how to address rising levels of e-cigarette use among youth.
Tags: Cnn, Fda, US Food and Drug Administration


Pharma Stock Roundup: Regulatory Updates in Focus at PFE, BMY, RHHBY, SNY

Pfizer's (PFE) tafamidis application gets FDA's priority review. Regulatory updates for Roche's (RHHBY) and Bristol-Myers'(BMY) cancer combination drugs in focus.
Tags: Science, Fda, Pfizer, Roche, Bristol Myers BMY


United States: FDA Issues Final Guidance On Data Integrity And Compliance With Drug CGMP - Duane Morris LLP

Data integrity means complete, consistent and accurate recording of data. This requires an original or true copy of contemporaneously recorded data that is attributable to a specific individual and is legible and accurate.
Tags: News, United States, Fda, Duane Morris LLP


Immunomedics' cancer treatment fails to win accelerated approval from the FDA

Immunomedics Inc said on Thursday the U.S. Food and Drug Administration declined to grant accelerated approval for its breast cancer treatment, sacituzumab.
Tags: Money, businessNews, Fda, U S Food and Drug Administration, Immunomedics, Immunomedics Inc


The FDA Is Trying to Make It Easier for Drug Companies to Provide Over-the-Counter Opioid Overdose Antidote

The move is part of a wider effort to reduce overdose deaths
Tags: News, Drugs, Uncategorized, Fda, Onetime


No, the government shutdown isn’t a ‘crisis’

This government shutdown is now longer than any in history. The media keep using the word “crisis.” “Shutdown sows chaos, confusion and anxiety!” says The Washington Post. “Pain spreads widely.” The New York Times headlined, it’s all “just too much!” But wait. Looking around America, I see people going about their business — families eating in restaurants, employees going to work, children playing in playgrounds, etc. I have to ask: Where’s the crisis? Pundits talk as if government is the most i...
Tags: England, Congress, California, Washington Post, Opinion, Washington, La, America, San Francisco, Barack Obama, Sport, Soccer, New York Times, Fda, Tsa, Lausd


FDA to investigate safety of stents, balloons coated with paclitaxel

Researchers in December flagged higher patient death rates, but device companies have questioned the findings.
Tags: Fda


Shutdowns don’t get bad linearly; they get bad exponentially

Federal employees missed their first paycheck last week; from here on in, every milestone dramatically exacerbates the pain of the shutdown: a halt to aviation as TSA screeners quit en masse, civil cases stall in federal courts, 38 million hungry Americans denied food stamps and 10% of food sales in the US vanishing; deals expiring with the landlords of 40,000 low income households; then 2.2 million more households are imperiled; landlords renting to federal agencies will go without rent but wo...
Tags: Post, News, Washington, US, Barack Obama, Fda, Tsa, Shutdown, Trumpism, Center for American Progress, Office of Management and Budget, American Carnage, Federal Transport Agency, Sam Berger, Christopher Flavelle Jennifer A Dlouhy, Ryan Beene Bloomberg


FDA Clears Epilepsy Smartwatch for Use in Kids

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 AM
Tags: Fda


FDA approves generic drug for treating focal seizures

The U.S. Food and Drug Administration approved the first generic version of Sabril (vigabatrin) 500 mg tablets for treating complex partial seizures, also called focal seizures, as an adjunctive therapy (given with another primary treatment) in patients 10 years and older who have responded inadequately to several alternative (refractory) treatments.
Tags: Health, Fda, U S Food and Drug Administration


U.S. shutdown taking toll on FDA, USDA inspection roles: experts

Workers in public health laboratories are reporting disruptions in the analysis of DNA from food samples involved in foodborne outbreaks, and have raised concerns about a USDA program that tests agricultural commodities for unsafe levels of pesticides, they said. The shutdown is "putting our nation's food supply at risk," Connecticut Representative Rosa DeLauro, a Democrat, said at a briefing of the House Congressional Food Safety Caucus on Wednesday. Only about a third of the FDA's regular i...
Tags: News, Usda, Connecticut, Fda, Rosa, FDA USDA, House Congressional Food Safety Caucus


Experimental Treatment Helps Maryland Woman Beat Lymphoma

Our dear friend Dr. Pashna Munshi is part of the team that is working on this experimental treatment for Lymphoman. A Maryland woman who suffered a lengthy battle with stage-three non-Hodgkin lymphoma is now in complete remission after receiving a promising new treatment that uses a patient’s own cells to fight cancer. Daisy Diggs, 67, is the first patient to do the CAR-T cell procedure at MedStar Georgetown University Hospital as part of a clinical trial. Article By Aimee Cho, www.nbcwashingt...
Tags: Maryland, Medicine, Life, Fda, Hodgkin, Diggs, MedStar Georgetown University Hospital, MedStar Georgetown, Munshi, Maryland Woman Beat Lymphoma, Pashna Munshi, Daisy Diggs, Aimee Cho, Diggs Munshi


Amgen's postmenopausal osteoporosis drug wins FDA panel backing

An advisory panel to the U.S. Food and Drug Administration on Wednesday recommended Amgen Inc's osteoporosis treatment for postmenopausal women at high risk for fracture, saying the benefits of the drug outweighed its risks. The panel, however, raised concerns of the cardiovascular safety risks linked to the drug, which FDA staff reviewers on Monday had cited as the main reason for convening the panel meeting. "I don't think we've adequately characterized cardiovascular safety ... I don't know...
Tags: Science, Fda, Amgen, U S Food and Drug Administration, Amgen Inc, Pamela Shaw


Why You Shouldn't Use Teething Necklaces for Your Baby

If you rely on teething necklaces to keep your baby’s pain at bay, the FDA wants you to stop. But they’re not just being big meanies—kids have choked and strangled on teething necklaces, and the amber ones made claims that were always too good to be true. Read more...
Tags: Parenting, Safety, Babies, Fda, Lifehacks, Teething


The Incurable Disease vs the Relentless Couple

When Sonia Vallabh lost her mother to a rare disease called fatal familial insomnia, she soon found out that she had inherited the disease, that there was no cure, and that she’d be dead in “a decade or two”. Despite almost no scientific training, Vallabh and her husband both quit their jobs to work on a cure. Talk about going all-in. Within a few weeks of the diagnosis, Sonia had quit her job to study science full time, continuing classes at MIT during the day and enrolling in a night class in...
Tags: Mit, Harvard, Lander, Fda, National Geographic, Max, Jason Kottke, Eric, HUNTINGTON, Sonia, Schreiber, Vallabh, Sonia Vallabh, Minikel


FDA Alerts Pet Owners About Recalls of Several Dry Pet Foods

Recalls were issued after the FDA received complaints that dogs consuming the potentially tainted brands experienced vitamin D toxicity.
Tags: News, Fda


FDA: five weeks till money runs out for approving new drugs

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.
Tags: News, Stories, Fda, US Food and Drug Administration, Scott Gottlieb


The FDA has five weeks till money runs out for approving new drugs

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.
Tags: Cnn, Fda, US Food and Drug Administration, Scott Gottlieb


After 33 Exits in 5 Years, WI Seeks “More and Bigger” Startup Deals

When Propeller Health’s founders initially tried to raise funding for their new healthcare technology venture, many of the investors they spoke with were hesitant to take the risk.It was the early part of this decade, and Propeller was navigating the FDA’s regulatory process for medical devices. The company believed it had a chance to become one of the first to earn market clearance from the agency for a software product, says Propeller co-founder and CEO David Van Sickle. Propeller’s idea for ...
Tags: Deals, Startups, Mobile, Apps, Internet Of Things, Education, Connected Devices, Trends, Tech, It, Cybersecurity, Walgreens, Vc, Software, Healthcare, M&a


Flavocure Announces Initiation of IND Enabling Studies for Drug to Treat Pancreatic and Glioblastoma Cancers

Baltimore, Maryland--(Newsfile Corp. - January 16, 2019) -  Flavocure Biotech, Inc., announced today that it has initiated Investigational New Drug (IND) enabling studies for its cannabis derived drug, FBL-03G. The studies, which are estimated to cost over $1 million, have been independently sponsored by the company's Executive Vice Chairman, Clark Swanson. The commitment paves the way for Flavocure to attain IND status from the FDA. The effort is expected to be ...
Tags: Science, Fda, Glioblastoma Cancers, Baltimore Maryland Newsfile Corp, Flavocure Biotech Inc, Clark Swanson