Ipsen ’s Onivyde Regimen, a Potential New Standard-of-Care First-Line Therapy in Metastatic Pancreatic Adenocarcinoma, Approved by FDA
PARIS, FRANCE, 13 February 2024– Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application for Onivyde (irinotecan liposome injection) plus... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 13, 2024 Category: Drugs & Pharmacology Source Type: news

FDA Warns Online Vendors Selling Misbranded Weight-loss, Diabetes Drugs FDA Warns Online Vendors Selling Misbranded Weight-loss, Diabetes Drugs
The U.S. Food and Drug Administration said on Tuesday it has sent warning letters to two online vendors for selling unapproved and misbranded versions of semaglutide and...Reuters Health Information (Source: Medscape Diabetes Headlines)
Source: Medscape Diabetes Headlines - February 13, 2024 Category: Endocrinology Tags: Diabetes & Endocrinology Source Type: news

FDA Roundup: February 13, 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 - February 13, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

DOSIsoft receives FDA clearance for ThinkQA Secondary Dose Check
DOSIsoft has obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its ThinkQA (Edition 2) Secondary Dose Check. ThinkQA is a tool for patient quality assurance for external beam radiation therapy (EBRT). It offers automated and 3D independent calculation-based dose verification for both offline and online adaptive workflows. DOSIsoft highlighted ThinkQA's web platform and dashboard for qualified professional users to visualize 3D dose distribution comparisons and key dosimetric indicators. These include whole matrix differential and cumulative dose volume histograms and gamma index agreements on...
Source: AuntMinnie.com Headlines - February 13, 2024 Category: Radiology Authors: AuntMinnie.com staff writers Tags: Industry News Source Type: news

FDA approves irinotecan liposome for first-line treatment of metastatic pancreatic adenocarcinoma
On February 13, 2024, the Food and Drug Administration approved irinotecan liposome (Onivyde, Ipsen Biopharmaceuticals, Inc.) with oxaliplatin, fluorouracil, and leucovorin, for the first-line treatment of metastatic pancreatic adenocarcinoma. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 13, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Butterfly Network launches Butterfly iQ3
Butterfly Network has launched its third-generation handheld point-of-care ultrasound (POCUS) system, Butterfly iQ3, which in January received clearance from the U.S. Food and Drug Administration (FDA). Butterfly iQ3 is powered by a semiconductor chip with a data transfer rate that is double that of its predecessor, the company said. It also features a novel “no focus” rubber lens, allowing providers to identify anatomy, observe small structures, and make more confident diagnostic decisions. Launching on Butterfly iQ3 are two new 3D imaging capabilities designed to make image capturing easier: iQ Slice and iQ Fan...
Source: AuntMinnie.com Headlines - February 13, 2024 Category: Radiology Authors: AuntMinnie.com staff writers Tags: Industry News Source Type: news

Nanox gets FDA nod for HealthFLD liver attenuation software
Nanox's deep-learning medical imaging analytics subsidiary, Nanox AI, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for HealthFLD liver attenuation software. HealthFLD provides automated qualitative and quantitative analysis of liver attenuation from routine contrast and non-contrast chest and abdomen CT scans. The company highlighted HealthFLD's performance in a 2023 study of nearly 3,000 patients, which found that the software achieved a sensitivity of 77.8% and specificity of 93.2% at less than 80 HU. This marks the third product in Nanox AI’s suite of population health software pro...
Source: AuntMinnie.com Headlines - February 13, 2024 Category: Radiology Authors: AuntMinnie.com staff writers Tags: Industry News Source Type: news

FDA Approves Eohilia (budesonide oral suspension) for the Treatment of Eosinophilic Esophagitis
OSAKA, Japan and CAMBRIDGE, Massachusetts, February 12, 2024– Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved Eohilia (budesonide oral suspension), the first and only FDA-approved oral... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 12, 2024 Category: Drugs & Pharmacology Source Type: news

Stock Up 8% Today?
A positive news update for Mind Medicine (NASDAQ: ) is elevating the entire psychedelic treatment sector today. Specifically, the U.S. Food and Drug Administration (FDA) has just granted midomafetamine capsules (MDMA) a priority review. If this results in regulatory approval, MindMedicine’s…#mindmedicine #fda #mdma #ntmindmedicine #lykostherapeutics #numinuswellness #compasspathways #bankofnewyorkmellon #alexsirois #lykos (Source: Reuters: Health)
Source: Reuters: Health - February 12, 2024 Category: Consumer Health News Source Type: news

More Pregnant People Are Relying on Early Prenatal Testing As States Toughen Abortion Laws
WASHINGTON — In Utah, more of Dr. Cara Heuser’s maternal-fetal medicine patients are requesting early ultrasounds, hoping to detect serious problems in time to choose whether to continue the pregnancy or have an abortion. In North Carolina, more obstetrics patients of Dr. Clayton Alfonso and his colleagues are relying on early genetic screenings that don’t provide a firm diagnosis. [time-brightcove not-tgx=”true”] The reason? New state abortion restrictions mean the clock is ticking. Since Roe v. Wade was overturned, many health care providers say an increasing number of patient...
Source: TIME: Health - February 12, 2024 Category: Consumer Health News Authors: LAURA UNGAR and AMANDA SEITZ Tags: Uncategorized healthscienceclimate wire Source Type: news

Sant é's Expert Commentary on the Danger of Tianeptine or "Gas Station Heroin"
The U.S. Food and Drug Administration (FDA) recently issued a new and urgent warning about using any products, such as Neptune's Fix, that contain tianeptine. Tianeptine, commonly known as "gas station heroin," is an unapproved drug in the U.S. ARGYLE, Texas, Feb. 12, 2024... (Source: PRWeb: Medical Pharmaceuticals)
Source: PRWeb: Medical Pharmaceuticals - February 12, 2024 Category: Pharmaceuticals Tags: PSF MAT Source Type: news

T2 Biosystems Receives FDA 510(k) Clearance for the Expanded T2Bacteria Panel
LEXINGTON, Mass., Feb. 12, 2024 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. TTOO, a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the expanded…#lexington #mass #t2biosystemsincttoo #fda #t2bacteriapanel #icu #johnsperzel #t2biosystems #paeruginosa #clinicians (Source: Reuters: Health)
Source: Reuters: Health - February 12, 2024 Category: Consumer Health News Source Type: news

FDA Accepts Xspray Pharma ’s NDA-Resubmission for Dasynoc
Stockholm, Sweden– 2024-02-12 Xspray Pharma AB (publ) (Nasdaq Stockholm: XSPRAY): The U.S. Food and Drug Administration (FDA) has accepted the resubmission of Xspray Pharma’s New Drug Application (NDA) for Dasynoc®, following a... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 12, 2024 Category: Drugs & Pharmacology Source Type: news

Cheese recall expands to dozens of products as two people die
The Food and Drug Administration (FDA) has expanded the number of food vendors who must recall products containing cheese from a California producer officials suspect may be behind a nationwide listeria outbreak that has been linked to two deaths and dozens of hospitalizations. On Saturday, the…#fda #rizolópezfoods #modesto #tacomeals #cdc #listeriabacteria #freshcreativefoods #staterbrosmarkets #savemartcompanies #savemart (Source: Reuters: Health)
Source: Reuters: Health - February 11, 2024 Category: Consumer Health News Source Type: news

The threat of fungal infections is growing. Why is it so hard to make new drugs?
Last summer, the Food and Drug Administration denied an application for a new antifungal drug called olorofim, sending it back to the company with a request for more data. If approved, it would have been the first time since the early 2000s that the FDA cleared an antifungal that works in an…#fda #arturocasadevall #baltimore #valley #greatplains #aspergillus #normanvanrhijn #unitedkingdom #leahcowen #universityoftoronto (Source: Reuters: Health)
Source: Reuters: Health - February 11, 2024 Category: Consumer Health News Source Type: news