Food and Drug Administration (FDA) News 
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This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.Practical Guidance for Successful Global Regulatory Submissions: Understanding FDA and PMDA Data Standards Requirements, Upcoming Webinar Hosted by Xtalks
In this free webinar, gain insights into the constantly evolving data standards requirements for regulatory submissions. The US Food and Drug Administration (FDA) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA) delineate these requirements through binding guidance documents,... (Source: PRWeb: Medical Pharmaceuticals)
Source: PRWeb: Medical Pharmaceuticals - March 6, 2024 Category: Pharmaceuticals Source Type: news
FDA Clears First OTC Continuous Blood Glucose Monitor
WEDNESDAY, March 6, 2024 -- The U.S. Food and Drug Administration on Tuesday approved the country ' s first continuous glucose monitor for type 2 diabetes.
The new Dexcom Stelo Glucose Biosensor System, which will be available by summer, is intended... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - March 6, 2024 Category: General Medicine Source Type: news
Dexcom announces its first-ever over-the-counter CGM Stelo has been cleared by the FDA
The Dexcom logo is seen on a smartphone screen and in the background. Dexcom on Tuesday announced that its new over-the-counter continuous glucose monitor called Stelo has been cleared for use by the U.S. Food and Drug Administration, and it will be available for purchase online this summer.…#dexcom #cgm #g7cgm #jeffshuren #fda #jakeleach #stelo #nvidia #whywarrenbuffett #franklintempleton (Source: Reuters: Health)
Source: Reuters: Health - March 6, 2024 Category: Consumer Health News Source Type: news
FDA Approves Besponsa (inotuzumab ozogamicin) for Pediatric Patients with Acute Lymphoblastic Leukemia
On March 6, 2024, the Food and Drug Administration approved inotuzumab ozogamicin (Besponsa, Pfizer) for pediatric patients 1 year and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL).
Efficacy was... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 6, 2024 Category: Drugs & Pharmacology Source Type: news
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.
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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
