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First OTC Continuous Blood Glucose Monitor Cleared for Marketing by FDA
WEDNESDAY, March 6, 2024 -- The first over-the-counter continuous glucose monitor (CGM) has been cleared for marketing by the U.S. Food and Drug Administration. The new Dexcom Stelo Glucose Biosensor System, which will be available by summer, is... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - March 6, 2024 Category: Pharmaceuticals Source Type: news

FDA: Ground Cinnamon Products May Contain Toxic Levels of Lead
WEDNESDAY, March 6, 2024 -- A health advisory has been issued by the U.S. Food and Drug Administration regarding six brands of ground cinnamon that contain elevated levels of lead. The FDA urged people to throw away and not buy the following brands... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - March 6, 2024 Category: Pharmaceuticals Source Type: news

Sauce recall as contamination fears spark warning of toxins
A recall was issued on Wednesday for a chili-flavored sauce over concerns that it could be contaminated with toxins. The U.S. Food and Drug Administration (FDA) announced that the California-based company Aji Mori Sauce Corp., DBA Sushi Koo, was issuing a voluntary recall for its "Chillimami…#fda #ajimorisaucecorp #sushikoo #chillimamisauce #canneryprogram #clostridium #fsis (Source: Reuters: Health)
Source: Reuters: Health - March 6, 2024 Category: Consumer Health News Source Type: news

FDA approves 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. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 6, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Warns of Toxic Lead in Cinnamon Products
WEDNESDAY, March 6, 2024 -- The U.S. Food and Drug Administration issued a health advisory Wednesday warning consumers that six brands of ground cinnamon are tainted with lead. The FDA urged folks to throw away and not buy the following brands of... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - March 6, 2024 Category: General Medicine Source Type: news

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