FDA signs off on first over-the-counter continuous glucose monitor
The U.S. Food and Drug Administration said Tuesday that the federal agency had approved an over-the-counter continuous glucose monitor for those who do not use insulin. (Source: Health News - UPI.com)
Source: Health News - UPI.com - March 5, 2024 Category: Consumer Health News Source Type: news

Cleerly CAD Staging System gets FDA nod
Cleerly's coronary artery disease (CAD) Staging System has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). The system is a noninvasive imaging-based investigational software device that analyzes features of coronary atherosclerosis, stenosis, and ischemia. It aims to support physicians with risk assessment for patients at risk of major adverse cardiovascular events (MACE), including heart attacks, before they happen. The Cleerly CAD Staging System was also accepted into the FDA’s Total Product Life Cycle Advisory Program (TAP) Pilot program, which helps companies make devic...
Source: AuntMinnie.com Headlines - March 5, 2024 Category: Radiology Authors: AuntMinnie.com staff writers Tags: Industry News Thoracic Imaging Source Type: news

FDA Approves Wyost (denosumab-bddz), an Interchangeable Biosimilar to Xgeva
Basel, March 5, 2024– Sandoz, the global leader in generic and biosimilar medicines, today announced that the US Food and Drug Administration (FDA) approved Wyost (denosumab-bbdz), an interchangeable biosimilar to Xgeva. The FDA also... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 5, 2024 Category: Drugs & Pharmacology Source Type: news

Roche and Alnylam report positive topline results from the Phase II KARDIA-2 study in people with hypertension, demonstrating clinically significant blood pressure reductions with zilebesiran when added to standard of care
KARDIA-2 study met its primary endpoint, demonstrating clinically significant systolic blood pressure reductions in each treatment arm at month threeZilebesiran added to a standard of care hypertension medication demonstrated an encouraging safety and tolerability profile in adults with mild to moderate uncontrolled hypertension, and results support the potential for twice-yearly dosingRoche and Alnylam have initiated the Phase II KARDIA-3 study in adults with uncontrolled hypertension at high cardiovascular riskKARDIA-2 study results will be presented as a late-breaking abstract in April at the 2024 American College of Ca...
Source: Roche Investor Update - March 5, 2024 Category: Pharmaceuticals Source Type: news

Roche and Alnylam report positive topline results from the Phase II KARDIA-2 study in people with hypertension, demonstrating clinically significant blood pressure reductions with zilebesiran when added to standard of care
KARDIA-2 study met its primary endpoint, demonstrating clinically significant systolic blood pressure reductions in each treatment arm at month threeZilebesiran added to a standard of care hypertension medication demonstrated an encouraging safety and tolerability profile in adults with mild to moderate uncontrolled hypertension, and results support the potential for twice-yearly dosingRoche and Alnylam have initiated the Phase II KARDIA-3 study in adults with uncontrolled hypertension at high cardiovascular riskKARDIA-2 study results will be presented as a late-breaking abstract in April at the 2024 American College of Ca...
Source: Roche Media News - March 5, 2024 Category: Pharmaceuticals Source Type: news

FDA Approves Jubbonti (denosumab-bddz), an Interchangeable Biosimilar to Prolia
Basel, March 5, 2024– Sandoz, the global leader in generic and biosimilar medicines, today announced that the US Food and Drug Administration (FDA) approved Jubbonti, (denosumab-bbdz), an interchangeable biosimilar to Prolia. The FDA also... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 5, 2024 Category: Drugs & Pharmacology Source Type: news

Clear Guide Scenergy system gets FDA clearance
The U.S. Food and Drug Administration (FDA) has approved Clear Guide Medical's Clear Guide Scenergy computer-aided instrument guidance system, alongside the company's TP Access Tool with SteriGRID. The system aims to improve image-guided diagnostic and interventional procedures by leveraging image fusion, instrument recognition and tracking, multimodal markers, and target planning functionalities, the system provides clinicians with a solution for in-suite MR-guided transperineal procedures. For transperineal biopsy procedures, Clear Guide Scenergy allows clinicians to guide biopsy needles through the perineal skin into ...
Source: AuntMinnie.com Headlines - March 5, 2024 Category: Radiology Authors: AuntMinnie.com staff writers Tags: Industry News Source Type: news

US FDA Approves Eyenovia's Eye Drug, Formosa Pharma Says US FDA Approves Eyenovia's Eye Drug, Formosa Pharma Says
The U.S. Food and Drug Administration had approved Eyenovia ' s eye drops to reduce inflammation and pain in patients who have undergone eye surgery, Taiwan-based Formosa...Reuters Health Information (Source: Medscape General Surgery Headlines)
Source: Medscape General Surgery Headlines - March 4, 2024 Category: Surgery Tags: Ophthalmology Source Type: news

FDA Says Yogurt Makers Can Make'Qualified' Claims About T2D Prevention
MONDAY, March 4, 2024 -- In a statement released Friday, the U.S. Food and Drug Administration said it will not object to yogurt manufacturers making " qualified health claims " that say there is some evidence that eating at least two cups of yogurt... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - March 4, 2024 Category: Pharmaceuticals Source Type: news

FDA Approves Letybo (letibotulinumtoxinA-wlbg) for the Treatment of Glabellar Lines
NEWPORT BEACH, Calif., March 4, 2024 /PRNewswire/ -- Hugel America, Inc., a division of Hugel Inc., a global leader in the medical aesthetics industry, today announced it received United States (U.S.) Food and Drug Administration (FDA) approval... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 4, 2024 Category: Drugs & Pharmacology Source Type: news

The First Over-the-Counter Birth Control Pill Is Here
The first birth control pill that people can buy without a prescription, called Opill, is shipping to stores this week. Perrigo, the Ireland-based company that makes Opill, said the pills should be available to purchase at retail pharmacies and online by the end of March. The pills are designed to be taken daily at about the same time each day, and they will be sold in one-month packs for $19.99 and three-month packs for $49.99. [time-brightcove not-tgx=”true”] A spokesperson for CVS, one pharmacy that will be stocking the pill, said the pills will be in more than 7,500 of its stores nationwide and will ...
Source: TIME: Health - March 4, 2024 Category: Consumer Health News Authors: Alice Park Tags: Uncategorized healthscienceclimate Source Type: news

FDA clears Lantheus' Definity for pediatric patients
The U.S. Food and Drug Administration (FDA) has cleared Lantheus Medical Imaging's Definity ultrasound contrast agent for pediatric patients. The FDA's decision was based on data from three pediatric trials conducted with Definity, Lantheus said; the three studies included a total of 189 patients. All reported adverse events across all trials were "mild, brief, and reversible without intervention," according to the firm. (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - March 4, 2024 Category: Radiology Authors: AuntMinnie.com staff writers Tags: Industry News Source Type: news

Zyn Is the New Vaping
Not so long ago, Juul was seen as the new Marlboro. Smoking wasn’t that cool anymore—rates had plummeted among U.S. adults and teens—but then came Juul, a sleek, addictive product with flashy advertising tactics that took off like wildfire. It soon became clear that e-cigarettes were hooking teens who otherwise wouldn’t have gone near nicotine. [time-brightcove not-tgx=”true”] Now, Juul is out and Zyn is in. It’s even more discreet than Juul, with no plumes of vapor. A user simply tucks a small pouch of nicotine, additives, and flavorings under their lip for up to an hour. Over...
Source: TIME: Health - March 4, 2024 Category: Consumer Health News Authors: Jamie Ducharme Tags: Uncategorized healthscienceclimate Source Type: news

Yogurt Makers Can Make Limited Claims About Type 2 Diabetes Prevention: FDA
MONDAY, March 4, 2024 -- Yogurt makers can now make limited claims about the food ' s power to help prevent type 2 diabetes, the U.S. Food and Drug Administration says. In a statement released Friday, the agency said it will not object to " qualified... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - March 4, 2024 Category: General Medicine Source Type: news

Cancer is no longer a death sentence, but treatments still have a long way to go
Recently, the US Food and Drug Administration approved a first-of-its-kind cancer therapy to treat aggresive forms of skin cancer. It has us thinking of the long history of cancer. One of the first recorded mentions of cancer appears in an ancient Egyptian text from around 3000 B.C. And although we now know much more about how cancer begins — as a series of mutations in someone's DNA — it's a disease people are still grappling with how to cure cancers today. This episode, cancer epidemiologist Mariana Stern talks about cancer history and treatment today — plus, why some people are more prone to certain cancers and wh...
Source: NPR Health and Science - March 4, 2024 Category: Consumer Health News Authors: Berly McCoy Source Type: news