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Management: Food and Drug Administration (FDA)
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Total 75 results found since Jan 2013.
FDA Approves Azstarys (serdexmethylphenidate and dexmethylphenidate) Capsules for the Once-Daily Treatment for ADHD
CELEBRATION, Fla., March 02, 2021 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ: KMPH), a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, today announced that the U.S. Food and Drug Administration...
Source: Drugs.com - New Drug Approvals - March 2, 2021 Category: Drugs & Pharmacology Source Type: news
Children with ADHD can now be prescribed a video game, FDA says
The first video game-based treatment for attention deficit hyperactivity disorder (ADHD) has been approved by the US Food and Drug Administration (FDA).
Source: CNN.com - Health - June 16, 2020 Category: Consumer Health News Source Type: news
FDA Approves ' Prescription Video Game ' for Kids With ADHD
TUESDAY, June 16, 2020 -- The first video game to help treat kids with attention-deficit/hyperactivity disorder (ADHD) has been approved by the U.S. Food and Drug Administration.
EndeavorRx is a prescription-only game designed to help improve...
Source: Drugs.com - Daily MedNews - June 16, 2020 Category: General Medicine Source Type: news
FDA Approves Video Game Made By Boston Company For Treating ADHD In Kids
BOSTON (AP) — The U.S. Food and Drug Administration has for the first time approved a video game for treating attention deficit hyperactivity disorder in children.
The FDA said Monday the game built by Boston-based Akili Interactive Labs can improve attention function.
The game, called EndeavorRx, requires a prescription and is designed for children ages 8 to 12 with certain symptoms of ADHD.
It’s the first time the FDA has cleared a digital therapy for improving ADHD symptoms, and the first time the agency has ever authorized marketing of a game-based therapy for any condition.
Screenshot of EndeavorRx (Photo cred...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - June 16, 2020 Category: Consumer Health News Authors: Health – CBS Boston Tags: Boston News Health Syndicated CBSN Boston ADHD Children With ADHD EndeavorRx FDA Source Type: news
FDA approves video game for treating ADHD in kids
The U.S. Food and Drug Administration has for the first time approved a video game for treating attention deficit hyperactivity disorder in children
Source: ABC News: Health - June 16, 2020 Category: Consumer Health News Tags: Health Source Type: news
Supernus Pharmaceuticals seeks FDA approval for ADHD drug
The fate of a local company ’s treatment for attention deficit hyperactivity disorder is now in regulators’ hands.
Supernus Pharmaceuticals Inc. (NASDAQ: SUPN) has submitted its application to the Food and Drug Administration to take its ADHD drug to market, the company announced Monday. If granted, that could mean gettin g the treatment to patients in the second half of 2020.
Supernus has put the product candidate through a handful of phase 3 clinical trials, to study its ability to reduce ADHD…
Source: bizjournals.com Health Care:Pharmaceuticals headlines - November 13, 2019 Category: Pharmaceuticals Authors: Sara Gilgore Source Type: news
There ’s ‘Scarce Evidence’ to Suggest Cannabis Improves Mental Health Symptoms, a New Research Review Says
Marijuana is more mainstream than it’s ever been. A growing number of states are legalizing it medicinally and recreationally; millions of people are vaping products that contain the compound THC (potentially to the detriment of their health); and non-psychoactive CBD is in everything from beauty products to seltzer water. This spring, Google searches for CBD exceeded searches for buzzy health topics like acupuncture, apple cider vinegar and meditation, according to a recent JAMA Network Open analysis.
The problem: Even though many consumers turn to cannabis compounds, known as cannabinoids, to soothe issues like dep...
Source: TIME: Health - October 28, 2019 Category: Consumer Health News Authors: Jamie Ducharme Tags: Uncategorized Mental Health/Psychology Source Type: news
US health officials approve battery-powered device to treat ADHD
The US's Food and Drug Administration will now allow doctors to prescribe an electrical nerve stimulating device for seven to 12-year-olds. It has also been tested for PTSD sufferers (pictured).
Source: the Mail online | Health - April 25, 2019 Category: Consumer Health News Source Type: news
FDA permits marketing of first medical device for treatment of ADHD
The U.S. Food and Drug Administration permitted marketing of the first medical device to treat attention deficit hyperactivity disorder (ADHD). The prescription-only device, called the Monarch external Trigeminal Nerve Stimulation (eTNS) System, is indicated for patients ages 7 to12 years old who are not currently taking prescription ADHD medication and is the first non-drug treatment for ADHD granted marketing authorization by the FDA.
Source: World Pharma News - April 23, 2019 Category: Pharmaceuticals Tags: Featured FDA Regulatory Affairs Source Type: news
FDA Clears First Device for Treating ADHD FDA Clears First Device for Treating ADHD
The US Food and Drug Administration has granted marketing authorization for the Monarch external trigeminal nerve stimulation system to treat ADHD in patients between the ages of 7 and 12 years.FDA Approvals
Source: Medscape Psychiatry Headlines - April 22, 2019 Category: Psychiatry Tags: Psychiatry News Alert Source Type: news
FDA Approves First Medical Device To Treat ADHD In Children
(CNN) — The first medical device to treat childhood attention deficit hyperactivity disorder, or ADHD, was OK’d Friday by the US Food and Drug Administration. Designated for children ages 7 to 12 who are not currently on medication for the disorder, the device delivers a low-level electrical pulse to the parts of the brain responsible for ADHD symptoms.
“This new device offers a safe, non-drug option for treatment of ADHD in pediatric patients through the use of mild nerve stimulation, a first of its kind,” Carlos Peña, director of the Division of Neurological and Physical Medicine Devices in the F...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - April 22, 2019 Category: Consumer Health News Authors: Health – CBS Boston Tags: Health News CNN ADHD Source Type: news
FDA Approves Marketing of First Device to Treat ADHD
MONDAY, April 22, 2019 -- Marketing has been approved for the first medical device to treat attention-deficit/hyperactivity disorder (ADHD), the U.S. Food and Drug Administration announced Friday.
The Monarch external Trigeminal Nerve Stimulation...
Source: Drugs.com - Pharma News - April 22, 2019 Category: Pharmaceuticals Source Type: news
FDA OKs first medical device to treat ADHD in children
The first medical device to treat attention deficit hyperactivity disorder, or ADHD, was approved Friday by the Food and Drug Administration. Instead of medication, the device delivers a low-level electrical stimulation to the parts of the brain that regulate emotion, behavior and attention.
Source: CNN.com - Health - April 20, 2019 Category: Consumer Health News Source Type: news
FDA permits marketing of first medical device for treatment of ADHD
Source: Food and Drug Administration - April 19, 2019 Category: American Health Source Type: news
