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)
Source: Medscape Psychiatry Headlines - April 22, 2019 Category: Psychiatry Tags: Psychiatry News Alert Source Type: news

Statement from Peter Marks, M.D., Ph.D., director of FDA ’s Center for Biologics Evaluation and Research, on FDA’s continued confidence in the safety and effectiveness of the measles, mumps, and rubella (MMR) vaccine
The FDA wants to underscore our continued confidence in the safety and effectiveness of the vaccines that are highly successful at preventing – in some cases, nearly eradicating – preventable diseases. Large well-designed studies have confirmed the safety and effectiveness of the MMR vaccine and have demonstrated that administration of the vaccine is not associated with the development of autism. MMR vaccine has been approved in the U nited States for nearly 50 years to prevent measles, mumps and rubella (also known as German Measles). As a result of its use, measles and rubella were completely eradicated in th...
Source: Food and Drug Administration - April 22, 2019 Category: American Health 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...
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)
Source: Drugs.com - Pharma News - April 22, 2019 Category: Pharmaceuticals Source Type: news

Merck's Keytruda wins FDA approval as combination therapy for kidney cancer
The U.S. Food and Drug Administration has approved Merck& Co Inc's cancer therapy, Keytruda, as part of a combination therapy for previously untreated patients with the most common type of kidney cancer, the company said on Monday. (Source: Reuters: Health)
Source: Reuters: Health - April 22, 2019 Category: Consumer Health News Tags: healthNews Source Type: news

GE gets FDA nod for deep-learning CT reconstruction
GE Healthcare has received clearance from the U.S. Food and Drug Administration...Read more on AuntMinnie.comRelated Reading: GE to integrate Edison platform with ACR AI-LAB GE wins risk-sharing contract from Adventist Health GE focuses on artificial intelligence at ECR 2019 GE/Danaher deal does not include contrast business GE CEO reaffirms plan to float up to half of healthcare (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - April 22, 2019 Category: Radiology Source Type: news

Alvogen Inc. Issues Voluntary Nationwide Recall of Fentanyl Transdermal System Due to Product Mislabeling
Alvogen, Inc. is voluntarily recalling two lots of Fentanyl Transdermal System 12 mcg/h transdermal patches to the consumer level. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 21, 2019 Category: Food Science 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)
Source: CNN.com - Health - April 20, 2019 Category: Consumer Health News Source Type: news

FDA Approves First Generic Naloxone Nasal Spray to Treat Opioid Overdose
April 19, 2019 -- The U.S. Food and Drug Administration today granted final approval of the first generic naloxone hydrochloride nasal spray, commonly known as Narcan, a life-saving medication that can stop or reverse the effects of an opioid... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - April 20, 2019 Category: Pharmaceuticals Source Type: news

FDA permits marketing of first medical device for treatment of ADHD
(Source: Food and Drug Administration)
Source: Food and Drug Administration - April 20, 2019 Category: American Health Source Type: news

FDA Approves First Generic Nasal Spray Against Opioid Overdose
FRIDAY, April 19, 2019 -- The first generic naloxone nasal spray to treat opioid overdose has received approval from the U.S. Food and Drug Administration. Teva Pharmaceuticals'lifesaving product is also the first generic naloxone nasal spray... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - April 19, 2019 Category: Pharmaceuticals Source Type: news

FDA approves first generic naloxone nasal spray to treat opioid overdose
The U.S. Food and Drug Administration today granted final approval of the first generic naloxone hydrochloride nasal spray, commonly known as Narcan, a life-saving medication that can stop or reverse the effects of an opioid overdose. The agency is also planning new steps to prioritize the review of additional generic drug applications for products intended to treat opioid overdose, along with the previously announced action to help facilitate an over-the-counter naloxone product. (Source: World Pharma News)
Source: World Pharma News - April 19, 2019 Category: Pharmaceuticals Tags: Featured FDA Regulatory Affairs Source Type: news

Recall Of Blood Pressure Drug Losartan Expanded
(CNN) — If you take blood pressure medicine, you’ll want to double-check your bottle. Torrent Pharmaceuticals Ltd. has expanded its recall of losartan potassium and losartan potassium/hydrochlorothiazide tablets. Tests found trace amounts of a potentially cancer-causing impurity called N-methylnitrosobutyric acid in some of these drugs. The company is recalling 36 additional lots, it said Thursday. A full list of recalled drugs is available on the US Food and Drug Administration website. Some of the recalled blood pressure medication (Image credit: FDA) The company hasn’t had any reports of users getting ...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - April 19, 2019 Category: Consumer Health News Authors: Health – CBS Boston Tags: Health News losartan Source Type: news

FDA approves Teva's generic nasal spray to treat opioid overdose
Generic drugmaker Teva Pharmaceutical Industries Ltd on Friday received approval from the U.S. Food and Drug Administration (FDA) to market its generic nasal spray for opioid overdose, the health regulator said. (Source: Reuters: Health)
Source: Reuters: Health - April 19, 2019 Category: Consumer Health News Tags: healthNews Source Type: news

The FDA Just Approved the First Generic Nasal Spray to Reverse Opioid Overdoses
The Food and Drug Administration (FDA) on Friday announced that it granted final approval to the first generic naloxone hydrochloride nasal spray, which can be used to reverse opioid overdoses. The approval is part of the FDA’s wider effort to make tools for stopping or preventing opioid overdoses more accessible and widely used. The agency is also working with drug companies to bring over-the-counter versions of naloxone to market, and is prioritizing the approval of other generic naloxone products. Friday’s announcement, which makes official a tentative approval previously granted to Teva Pharmaceuticals, mea...
Source: TIME: Health - April 19, 2019 Category: Consumer Health News Authors: Jamie Ducharme Tags: Uncategorized Drugs Source Type: news

FDA approves first generic naloxone nasal spray to treat opioid overdose
FDA granted approval of the 1st generic naloxone hydrochloride nasal spray, commonly known as Narcan, a life-saving medication that can stop or reverse the effects of an opioid overdose (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 19, 2019 Category: American Health Source Type: news

MedImmune spinoff scores breakthrough status for rare autoimmune disease treatment
Viela Bio Inc. has earned a breakthrough therapy designation from the Food and Drug Administration for a product to treat neuromyelitis optica spectrum disorder, a life-threatening autoimmune disease that impacts the central nervous system. The FDA granted breakthrough status to the company’s candidate, inebilizumab, following positive results from a pivotal study that was “the largest monotherapy study ever conducted in NMOSD,” said Dr. Jorn Drappa, chief medical officer and head of research… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - April 19, 2019 Category: Biotechnology Authors: Sara Gilgore Source Type: news

FDA Approves 1st Generic Naloxone Nasal Spray Against Opioid Overdose
FRIDAY, April 19, 2019 -- The first generic naloxone nasal spray to treat opioid overdose has received approval from the U.S. Food and Drug Administration. Teva Pharmaceuticals'lifesaving product is also the first generic naloxone nasal spray... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - April 19, 2019 Category: General Medicine Source Type: news

FDA Approves First Generic Naloxone Nasal Spray Against Opioid Overdose
FRIDAY, April 19, 2019 -- The first generic naloxone nasal spray to treat opioid overdose has received approval from the U.S. Food and Drug Administration. Teva Pharmaceuticals'lifesaving product is also the first generic naloxone nasal spray... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - April 19, 2019 Category: General Medicine Source Type: news

Brain-injury device licensed by Health Canada was rejected by the FDA
The U.S. Food and Drug Administration's refusal to license a therapeutic device intended to help brain-injured people is raising questions about the rigour of Health Canada's approval process. (Source: CBC | Health)
Source: CBC | Health - April 19, 2019 Category: Consumer Health News Tags: News/Health Source Type: news

Updated: Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium/Hydrochlorothiazide Tablets, USP
Torrent Pharmaceuticals Limited is expanding its recall for Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. The Recall is expanded to include an additional 36 lots of Losartan potassium Tablets USP and 68 lots of Losartan Potassium/Hydrochlorothiazide Tablets, USP (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 18, 2019 Category: Food Science Source Type: news

Beckman Coulter's Early Sepsis Indicator Receives 510(k) Clearance from the U.S. Food and Drug Administration
New hematologic biomarker has the potential to revolutionize clinicians' approach to sepsis triage and diagnosis BREA, Calif., April 18, 2019 -- (Healthcare Sales & Marketing Network) -- A major milestone on its strategic mission to lead in sepsis diag... Devices, Diagnostics, FDA Beckman Coulter, Early Sepsis Indicator (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - April 18, 2019 Category: Pharmaceuticals Source Type: news

Weis Markets Issues Recall for Undeclared Egg Allergen In WQ Banana Puddin Ice Cream
Weis Markets today said it has issued a recall for its Weis Quality Banana Puddin Ice Cream (48oz) since the product ’s ingredient label fails to list an egg allergen due to a supplier error. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction if they consume these products. There have been no reports of illness from customer’s consuming this product to date. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 18, 2019 Category: Food Science Source Type: news

Mondel ēz Global LLC Conducts Voluntary Recall of Certain Chewy Chips Ahoy 13oz Due to Unexpected Solidified Ingredient in Product in the US
Mondel ēz Global LLC announced today a limited voluntary recall in the United States of certain Chewy Chips Ahoy 13oz cookies. This voluntary recall is being conducted because of the potential for certain product to contain an unexpected solidified ingredient. Some reports of potential adverse health eff ects have been received. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 17, 2019 Category: Food Science Source Type: news

Mondel ē z Global LLC Conducts Voluntary Recall of Certain Chewy Chips Ahoy 13oz Due to Unexpected Solidified Ingredient in Product in the US
Mondel ē z Global LLC announced today a limited voluntary recall in the United States of certain Chewy Chips Ahoy 13oz cookies. This voluntary recall is being conducted because of the potential for certain product to contain an unexpected solidified ingredient. Some reports of potential adverse health effects have been received. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 17, 2019 Category: Food Science Source Type: news

FDA Grants Breakthrough Device Designation For Advanced Prenatal Therapeutics' Targeted Apheresis Column For Preeclampsia
LAGUNA HILLS, Calif., April 17, 2019 -- (Healthcare Sales & Marketing Network) -- Advanced Prenatal Therapeutics, Inc. (APT) announced today that the U.S. Food and Drug Administration (FDA) granted a Breakthrough Device Designation for APT's Targeted Aphe... Devices, FDA Advanced Prenatal Therapeutics, Targeted Apheresis Column, Preeclampsia (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - April 17, 2019 Category: Pharmaceuticals Source Type: news

FDA Approves Expanded Monotherapy Label for Merck ’s Keytruda (pembrolizumab) for First-Line Treatment of NSCLC
KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded label for Keytruda, Merck’s anti-PD-1 therapy, as... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 17, 2019 Category: Drugs & Pharmacology Source Type: news

F.D.A. Halts U.S. Sales of Pelvic Mesh, Citing Safety Concerns for Women
Boston Scientific and Coloplast were the last two companies selling the medical devices, which have resulted in nearly $8 billion in settlements. (Source: NYT Health)
Source: NYT Health - April 17, 2019 Category: Consumer Health News Authors: SHEILA KAPLAN and MATTHEW GOLDSTEIN Tags: Pelvis Medical Devices Women and Girls Surgery and Surgeons Boston Scientific Corporation Food and Drug Administration Coloplast Corp. transvaginal mesh your-feed-science pelvic organ prolapse Source Type: news

FDA bans sales of transvaginal mesh amid safety concerns
Manufacturers of surgical mesh products must stop selling and distributing their products in the United States immediately, the US Food and Drug Administration ordered Tuesday. (Source: CNN.com - Health)
Source: CNN.com - Health - April 16, 2019 Category: Consumer Health News Source Type: news

Jensen Tuna of Louisiana is Voluntarily Recalling Frozen Ground Tuna Imported from JK Fish, Because it may Potentially be Contaminated with < em > Salmonella < /em >
Jensen Tuna of Louisiana is Voluntarily Recalling Frozen Ground Tuna Imported from JK Fish, Because it may Potentially be Contaminated with Salmonella. The frozen product, individually packaged in clear plastic one-pound bags, is sold in white wax 20 lb. boxes. The product is only sold as a wholesale case with twenty bags in each case. The lot numbers are z266, z271 and z272. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 16, 2019 Category: Food Science Source Type: news

FDA To Boston Scientific: Stop Selling Pelvic Mesh Tied To Injuries In Women
WASHINGTON (AP) — U.S. health regulators on Tuesday halted sales of a type of surgical mesh used to repair pelvic conditions in women, following years of patients’ reports of injuries and complications from the implants. The Food and Drug Administration ordered the two remaining makers of the mesh — Boston Scientific and Coloplast — to stop selling it immediately, saying the companies failed to show the mesh is safe for long-term use. Several other major manufacturers, including Johnson & Johnson, previously stopped making the mesh. The FDA action does not apply to surgical mesh used to treat ot...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - April 16, 2019 Category: Consumer Health News Authors: Health – CBS Boston Tags: Boston News Health Boston Scientific FDA Source Type: news

FDA orders transvaginal surgical mesh pulled from market
The U.S. Food and Drug Administration on Tuesday ordered makers of transvaginal surgical mesh implants to immediately stop their sale and distribution in the United States, the latest action by the agency to tackle safety issues related to the devices. (Source: Reuters: Health)
Source: Reuters: Health - April 16, 2019 Category: Consumer Health News Tags: healthNews Source Type: news

FDA Halts All Sales of Pelvic Mesh Products Tied to Injuries in Women
TUESDAY, April 16, 2019 -- The U.S. Food and Drug Administration on Tuesday announced a ban on the sale of all pelvic mesh products. " In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - April 16, 2019 Category: Pharmaceuticals Source Type: news

Stop selling transvaginal surgical mesh for pelvic organ prolapse, U.S. FDA orders
The U.S. Food and Drug Administration on Tuesday ordered makers of transvaginal surgical mesh implants to immediately stop sale and distribution of the products in the United States. (Source: CBC | Health)
Source: CBC | Health - April 16, 2019 Category: Consumer Health News Tags: News/Health Source Type: news

FDA Statement from Deputy Commissioner for Food Policy and Response Frank Yiannas on new steps to protect consumers from unlawful ingredients in dietary supplements
(Source: Food and Drug Administration)
Source: Food and Drug Administration - April 16, 2019 Category: American Health Source Type: news

Unilever Issues Allergy Alert on Undeclared Tree Nut in Limited Quantities of Ben & Jerry ’s Coconut Seven Layer Bar Bulk and Chunky Monkey Pint
Unilever is voluntarily recalling a limited quantity of Ben& Jerry ’s Coconut Seven Layer Bar bulk and Ben& Jerry ’s Chunky Monkey pints, which may inadvertently contain tree nuts including almonds, Brazil nuts, and hazelnuts that are not declared in the ingredient list or allergy information list. Both affected products include a “Contains Walnuts” and a “May contain other tree nuts” label on the bac k of the pack. Persons who have an allergy or severe sensitivity to these undeclared tree nuts run the risk of a serious or life-threatening allergic reaction if they consume the re...
Source: Food and Drug Administration - April 16, 2019 Category: Food Science Source Type: news

FDA takes action to protect women ’s health, orders manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop selling all devices
FDA informs companies that the agency is not approving their PMA applications and that they will have to remove their products from the market (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 16, 2019 Category: American Health Source Type: news

FDA takes action to protect women ’ s health, orders manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop selling all devices
FDA informs companies that the agency is not approving their PMA applications and that they will have to remove their products from the market (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 16, 2019 Category: American Health Source Type: news

Is Honey Healthy? Here ’s What Experts Say
Because it comes from nature — from bees, no less — honey has a health halo. But is honey really healthy? Here’s what dietitians say about the health benefits of honey. What is honey made of? Honey is made from nectar. “Bees collect the dilute-sugary nectar of flora plants, produce an enzymatic activity after ingestion, regurgitate it into honey cells and evaporate a high percentage of the water out of it, producing a super-sweet viscous liquid known as honey,” explains Dana Hunnes, a senior dietitian at Ronald Reagan UCLA Medical Center. The sweet substance is mostly fructose and glucose &mda...
Source: TIME: Health - April 16, 2019 Category: Consumer Health News Authors: Cassie Shortsleeve  Tags: Uncategorized Diet/Nutrition Source Type: news

FDA Halts All Sales of Pelvic Mesh Products Tied to Injuries in Women
TUESDAY, April 16, 2019 -- The U.S. Food and Drug Administration on Tuesday announced a ban on the sale of all pelvic mesh products. The surgical mesh is typically used to repair pelvic organ prolapse (POP) and incontinence, but reported side... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - April 16, 2019 Category: General Medicine Source Type: news

EVENITY ™ (romosozumab-aqqg) now available in the United States for the treatment of osteoporosis in postmenopausal women at high risk for fracture
Amgen (NASDAQ: AMGN) announced that EVENITY™ (romosozumab-aqqg) is now available for shipment to wholesalers in the U.S. EVENITY was approved by the U.S. Food and Drug Administration (FDA) on April 9, 2019, for the treatment of osteoporosis in postmenopausal women at high risk for fracture. (Source: World Pharma News)
Source: World Pharma News - April 16, 2019 Category: Pharmaceuticals Tags: Featured Amgen Business and Industry Source Type: news

Nose spray could treat depression in as little as TWO hours
The U.S. regulator, the Food and Drug Administration, last week approved the use of the spray for patients with depression that does not respond to other treatments. (Source: the Mail online | Health)
Source: the Mail online | Health - April 16, 2019 Category: Consumer Health News Source Type: news

New 'added sugars' labeling could save money and improve health
(Reuters Health) - The Food and Drug Administration's new mandatory rules requiring labels on all packaged foods and drinks to indicate the presence of so-called added sugars could have substantial health and cost saving benefits in the United States over the next two decades, a new study suggests. (Source: Reuters: Health)
Source: Reuters: Health - April 15, 2019 Category: Consumer Health News Tags: healthNews Source Type: news

Inova ends genetic tests that elicited FDA warning
Inova Health System will no longer offer a series of genetic tests after the Food and Drug Administration warned the system that it had illegally marketed them without the agency ’s required clearance. “The MediMap tests were intended to provide additional information to physicians in discussions with their patients regarding medication options,” reads an Inova statement, which said it began offering the tests as a tool for doctors based on industry guidelines, with t he understanding that the… (Source: bizjournals.com Health Care News Headlines)
Source: bizjournals.com Health Care News Headlines - April 15, 2019 Category: Health Management Authors: Sara Gilgore Source Type: news

Inova ends genetic tests that elicited FDA warning
Inova Health System will no longer offer a series of genetic tests after the Food and Drug Administration warned the system that it had illegally marketed them without the agency ’s required clearance. “The MediMap tests were intended to provide additional information to physicians in discussions with their patients regarding medication options,” reads an Inova statement, which said it began offering the tests as a tool for doctors based on industry guidelines, with t he understanding that the… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - April 15, 2019 Category: Biotechnology Authors: Sara Gilgore Source Type: news

FDA approves Wayne company's dissection repair device
The Food and Drug Administration granted marketing approval to Intact's Vascular's Tack Endovascular System on Monday. The Tack Endovascular System is a dissection repair device implanted in angioplasty patients with peripheral arterial disease. Dissections occur when the inflation of an angioplasty balloon, and the resulting mechanical stress, injures vessels. "Post-angioplasty dissections can significantly imp act patient outcomes," said Dr. William Gray, the president of the Lankenau Heart Institute… (Source: bizjournals.com Health Care News Headlines)
Source: bizjournals.com Health Care News Headlines - April 15, 2019 Category: Health Management Authors: John George Source Type: news

FDA approves Wayne company's dissection repair device
The Food and Drug Administration granted marketing approval to Intact's Vascular's Tack Endovascular System on Monday. The Tack Endovascular System is a dissection repair device implanted in angioplasty patients with peripheral arterial disease. Dissections occur when the inflation of an angioplasty balloon, and the resulting mechanical stress, injures vessels. "Post-angioplasty dissections can significantly imp act patient outcomes," said Dr. William Gray, the president of the Lankenau Heart Institute… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - April 15, 2019 Category: Biotechnology Authors: John George Source Type: news

EVENITY ™ (romosozumab-aqqg) Now Available In The United States For The Treatment Of Osteoporosis In Postmenopausal Women At High Risk For Fracture
New Therapy to Cost One-Third Less Than Other Bone-Building Agents Over Full Course of Therapy THOUSAND OAKS, Calif., April 15, 2019 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced that EVENITY™ (romosozumab-aqqg) is now available for shipment to wholesalers in the U.S. EVENITY was approved by the U.S. Food and Drug Administration (FDA) on April 9, 2019, for the treatment of osteoporosis in postmenopausal women at high risk for fracture. "Osteoporosis is a silent disease that can lead to devastating consequences. Unfortunately, only 20 percent of women who have experienced a fracture receive any...
Source: Amgen News Release - April 15, 2019 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

The FDA Just Approved a New Prescription Weight-Loss Drug. Here ’s How It Works
In a rare move, the Food and Drug Administration (FDA) has approved a novel prescription drug meant to help with weight loss and weight management. The drug, called Plenity and developed by Gelesis, has been cleared for overweight or obese adults with a body mass index of at least 25, even if they do not have other health problems. It should be used in conjunction with diet and exercise, the FDA says, and can also be taken alongside other weight-loss medications. That sweeping approval is noteworthy, says Dr. Caroline Apovian, who has studied Plenity in Gelesis-sponsored research and is the director of nutrition and weight...
Source: TIME: Health - April 15, 2019 Category: Consumer Health News Authors: Jamie Ducharme Tags: Uncategorized medicine Source Type: news

The FDA Just Approved a New Prescription Weight-Management Device. Here ’s How It Works
In a rare move, the Food and Drug Administration (FDA) has approved a novel prescription device meant to help with weight management. The product, called Plenity and developed by Gelesis, has been cleared for overweight or obese adults with a body mass index of at least 25, even if they do not have other health problems. It should be used in conjunction with diet and exercise, the FDA says, and can also be taken alongside other weight-loss medications. That sweeping approval is noteworthy, says Dr. Caroline Apovian, who has studied Plenity in Gelesis-sponsored research and is the director of nutrition and weight managemen...
Source: TIME: Health - April 15, 2019 Category: Consumer Health News Authors: Jamie Ducharme Tags: Uncategorized medicine Source Type: news