Food and Drug Administration (FDA) News 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.

GEHC touts FDA clearance of Ionic Health's nCommand Lite
GE HealthCare (GEHC) is touting the U.S. Food and Drug Administration (FDA) clearance of Ionic Health's nCommand Lite software, which GEHC will distribute.nCommand Lite offers remote patient scanning support, remote access for review of images, and the ability to connect off-site experts to hospital-based ones, GEHC said. It supports MR, CT, and PET/CT imaging. (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - March 25, 2024 Category: Radiology Authors: AuntMinnie.com staff writers Tags: Industry News Source Type: news

Lumicell touts Lumisight clinical results
Lumicell highlighted clinical results presented at the recent Society of Surgical Oncology (SSO) in Atlanta, GA, that it says demonstrate the benefits of its Lumisight optical imaging agent for breast cancer. In 2023, the company submitted a new drug application (NDA) for Lumisight for use in patients with breast cancer undergoing a lumpectomy, along with a premarket approval (PMA) application for its Direct Visualization System (DVS). On March 5, the U.S. Food and Drug Administration's (FDA) Medical Imaging Drugs Advisory Committee (MIDAC) voted in support of Lumisight's benefit-risk profile, according to the firm. (S...
Source: AuntMinnie.com Headlines - March 25, 2024 Category: Radiology Authors: AuntMinnie.com staff writers Tags: Industry News Source Type: news

First Gene Therapy for Children With Metachromatic Leukodystrophy Approved by FDA
FRIDAY, March 22, 2024 -- The U.S. Food and Drug Administration has approved Lenmeldy (atidarsagene autotemcel) as the first gene therapy for the treatment of children with metachromatic leukodystrophy (MLD). Lenmeldy is a one-time, individualized... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - March 22, 2024 Category: Pharmaceuticals Source Type: news

FDA Roundup: March 22, 2024
SILVER SPRING, Md., March 22, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued an emergency use authorization for Pemgarda (pemivibart) for the pre-exposure prophylaxis (prevention)... (Source: PRWeb: Medical Pharmaceuticals)
Source: PRWeb: Medical Pharmaceuticals - March 22, 2024 Category: Pharmaceuticals Tags: FDA Source Type: news

FDA Roundup: March 22, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 22, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Approves Duvyzat (givinostat) for Duchenne Muscular Dystrophy
MILAN--(BUSINESS WIRE)-- Mar 22, 2024 -- Italfarmaco S.p.A. announced today that the U.S. Food and Drug Administration (FDA) has approved Duvyzat™ (givinostat), a novel histone deacetylase (HDAC) inhibitor, for the treatment of patients 6... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 22, 2024 Category: Drugs & Pharmacology Source Type: news

FDA Approves Opsynvi (macitentan and tadalafil) for Adults with Pulmonary Arterial Hypertension
RARITAN, NJ, March 22, 2024– Johnson& Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved Opsynvi®– a single-tablet combination of macitentan, an endothelin receptor antagonist (ERA), and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 22, 2024 Category: Drugs & Pharmacology Source Type: news

U.S. Food and Drug Administration (FDA) Grants Full Approval for Elahere (mirvetuximab soravtansine-gynx) for Certain Ovarian Cancer Patients
The full approval of Elahere is based on the confirmatory MIRASOL Phase 3 trial that supports the medicine as a potential new standard of care for folate receptor alpha (FRα)-positive, platinum-resistant ovarian cancer (PROC) Data show that... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 22, 2024 Category: Drugs & Pharmacology Source Type: news

U.S. FDA Approves Broad New Labels for Nexletol and Nexlizet to Prevent Heart Attacks and Cardiovascular Procedures in Both Primary and Secondary Prevention Patients, Regardless of Statin Use
ANN ARBOR, Mich., March 22, 2024 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced that the United States Food and Drug Administration (FDA) has approved broad new label expansions for Nexletol (bempedoic acid) Tablets and Nexlizet... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 22, 2024 Category: Drugs & Pharmacology Source Type: news

Medicare to Cover Wegovy When Patients Also Have Heart Disease
FRIDAY, March 22, 2024 -- Medicare will now cover the popular weight-loss drug Wegovy if patients using it also have heart disease, U.S. officials announced Thursday.The move comes after the U.S. Food and Drug Administration approved drugmaker Novo... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - March 22, 2024 Category: General Medicine Source Type: news

Exploring the association between suicidal thoughts, self-injury, and GLP-1 receptor agonists in weight loss treatments: insights from pharmacovigilance measures and unmasking analysis - Guirguis A, Chiappini S, Papanti P GD, Vickers-Smith R, Harris D, Corkery JM, Arillotta D, Floresta G, Martinotti G, Schifano F.
INTRODUCTION: The study addresses concerns about potential psychiatric side effects of Glucagon-like peptide-1 receptor agonists (GLP-1 RA). AIM: The aim of this work was to analyse adverse drug reports (ADRs) from the Food and Drug Administration ... (Source: SafetyLit)
Source: SafetyLit - March 22, 2024 Category: International Medicine & Public Health Tags: Ergonomics, Human Factors, Anthropometrics, Physiology Source Type: news

FDA cigarette warning labels satisfy First Amendment, US appeals court rules
A federal appeals court on Thursday said a U.S. Food and Drug Administration regulation requiring graphic warning labels on cigarette packages and advertisements is constitutional, handing a victory to the Biden administration and a defeat to the tobacco industry. Reversing a lower court ruling,…#neworleans #firstamendment #reynolds #itgbrands (Source: Reuters: Health)
Source: Reuters: Health - March 21, 2024 Category: Consumer Health News Source Type: news

Medicare now will cover weight-loss drug Wegovy for heart patients
Medicare now will cover Wegovy after the Food and Drug Administration cleared the manufacturer to market the popular weight-loss drug as a treatment for heart problems. (Source: Health News - UPI.com)
Source: Health News - UPI.com - March 21, 2024 Category: Consumer Health News Source Type: news

Siemens Healthineers' Ciartic Move gets FDA clearance
The U.S. Food and Drug Administration (FDA) has cleared Siemens Healthineers' Ciartic Move, a mobile C-arm with self-driving capabilities. The company said the system standardizes 2D fluoroscopic and 3D cone-beam CT imaging for surgeons and operating room teams in hospitals and outpatient facilities. Ciartic Move is designed to address the needs of orthopedic, trauma, and spine surgery. It can be used in thoracic, vascular, cardiovascular, and general surgery, as well as urology and interventional pulmonology.Ciartic Move. Image courtesy of Siemens Healthineers. The system is fully motorized from the C-arm down to its wh...
Source: AuntMinnie.com Headlines - March 21, 2024 Category: Radiology Authors: AuntMinnie.com staff writers Tags: Industry News Source Type: news

Shark Tank ’s Mark Cuban speaks out on Ozempic, weight-loss drugs
Ozempic, the medicine known generically as semaglutide, was approved by the U.S. Food and Drug Administration (FDA) in 2017 for type 2 diabetes patients. But the drug, manufactured by Denmark-based company Novo Nordisk (NVO) , has a side effect that is changing the way many people feel about one…#fda #denmark #novonordisk #nvo #elililly #lly #mounjaro #markcuban #dallas #sharktank (Source: Reuters: Health)
Source: Reuters: Health - March 21, 2024 Category: Consumer Health News Source Type: news