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.

XPlan.ai touts study evaluating x-ray based 3D model
RSIP Vision spinoff XPlan.ai is highlighting a new milestone for its x-ray-based 3D bone modeling system with the publication of a peer-reviewed clinical study published in the Journal of Clinical Medicine.The study, led by a consortium of orthopedic surgeons, found that XPlan.ai offers a promising alternative to conventional CT scans. XPlan.ai uses AI to produce 3D bone models from two standard x-ray images. Together with XPlan's automated planning technologies, this model can be used for surgical planning and navigation during orthopedic procedures such as total knee replacement.The company highlighted that the accurac...
Source: AuntMinnie.com Headlines - March 21, 2024 Category: Radiology Authors: AuntMinnie.com staff writers Tags: Industry News Source Type: news

PACS industry veteran returns to launch cloud workflow platform
If you’ve been around the PACS industry for a while, you’ll undoubtedly remember DR Systems, a vendor that launched in the early years of PACS and carved out a niche as an independent firm for over two decades. Its founder, Murray Reicher, MD, has now returned to the market with the launch of Synthesis Health, a radiology workflow platform developer. Reicher and colleagues believe their platform’s cloud-native architecture offers a compelling value proposition to radiology practices seeking streamlined workflow and greater efficiency. The Synthesis platform features several modules, including a workflow and repor...
Source: AuntMinnie.com Headlines - March 21, 2024 Category: Radiology Authors: Erik L. Ridley Tags: Imaging Informatics Enterprise Imaging Source Type: news

FDA: Revocation of Six Authorizations of Emergency Use of In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability
The Food and Drug Administration (FDA) has revoked 6 Emergency Use Authorizations issued to Life Technologies Corp.; Bio-Rad Laboratories, Inc.; Revvity, Inc.; bioM érieux SA; and Luminex Corp. related to COVID-19 detection and diagnosis tests. (Source: Federal Register updates via the Rural Assistance Center)
Source: Federal Register updates via the Rural Assistance Center - March 21, 2024 Category: Rural Health Source Type: news

Doctors Urge Refrigerating Acne Creams to Reduce Carcinogen Risk
Some dermatologists are recommending that people refrigerate benzoyl peroxide products such as Proactiv and Clearasil after an independent lab found they were contaminated with the potent carcinogen benzene. The American Acne & Rosacea Society said Wednesday that storing benzoyl peroxide creams, gels and washes at refrigerated temperatures could minimize the risk of benzene exposure. “Benzoyl peroxide has been a very important part of the treatment of many patients with acne and also some other skin diseases,” according to the group, which has about 6,000 members. [time-brightcove not-tgx=”trueR...
Source: TIME: Health - March 21, 2024 Category: Consumer Health News Authors: Anna Edney/Bloomberg Tags: Uncategorized bloomberg wire healthscienceclimate Source Type: news

FDA Approves Safety Labeling Changes Regarding DPD Deficiency for Fluorouracil Injection Products
On March 21, 2024, the Food and Drug Administration approved safety labeling changes for fluorouracil injection products. This effort was a collaboration between FDA’s Office of Generic Drugs and the Oncology Center of Excellence... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - March 21, 2024 Category: Pharmaceuticals Source Type: news

FDA Approves Tryvio (aprocitentan) for the Combination Treatment of Resistant Hypertension
RADNOR, Pa., March 20, 2024 /PRNewswire/ -- Idorsia Pharmaceuticals U.S. Inc. announced today that the US Food and Drug Administration (FDA) has approved Tryvio™ (aprocitentan) for the treatment of hypertension in combination with other... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 20, 2024 Category: Drugs & Pharmacology Source Type: news

FDA says safety issues with China-made syringes are'more widespread' than previously known
The U.S. Food and Drug Administration warned Tuesday that Chinese-made plastic syringes that are distributed in the U.S. have "more widespread" quality control issues than were previously known. In a safety communication, the agency said it found three Chinese syringe manufacturers were in…#fda #medlineindustrieslp #monthslong #irving #freseniusmedicalcare #fresenius (Source: Reuters: Health)
Source: Reuters: Health - March 20, 2024 Category: Consumer Health News Source Type: news

FDA Roundup: March 19, 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 19, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Takeda Announces U.S. FDA Approval of Supplemental New Drug Application (sNDA) for Iclusig (ponatinib) in Adult Patients with Newly Diagnosed Ph+ ALL
OSAKA, Japan and CAMBRIDGE, Massachusetts, March 19, 2024– Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Iclusig® (ponatinib) for... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 19, 2024 Category: Drugs & Pharmacology Source Type: news

FDA Approves Edurant PED (rilpivirine) for Certain Pediatric Patients Living with HIV-1
Titusville, NJ (March 19, 2024)– Johnson& Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved Edurant® PED (rilpivirine) for the treatment of HIV-1 in combination with other antiretroviral therapies... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 19, 2024 Category: Drugs & Pharmacology Source Type: news

FDA clears inHeart ’s digital twin of the heart
France-based medical device developer inHeart has received clearance from the U.S. Food and Drug Administration (FDA) for its AI-driven digital twin of the heart. The company’s AI software module offers interactive 3D models of the heart generated by AI that analyzes preprocedural CT or MR images. The technology has been proven useful in preplanning ventricular tachycardia ablations, a treatment for a type of irregular heartbeat, the company said. While the software has been commercially available to clinicians in Europe, FDA clearance now allows inHEART to market the product to hospitals across the U.S. (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - March 19, 2024 Category: Radiology Authors: AuntMinnie.com staff writers Tags: Industry News Source Type: news

FDA grants accelerated approval to ponatinib with chemotherapy for newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia
On March 19, 2024, the Food and Drug Administration granted accelerated approval to ponatinib (Iclusig, Takeda Pharmaceuticals U.S.A., Inc.) with chemotherapy f (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 19, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Approves First Drug to Treat Yeast Ear Infections in Dogs, DuOtic
TUESDAY, March 19, 2024 -- The U.S. Food and Drug Administration has approved the first drug to treat yeast ear infections in dogs. DuOtic is also the first ear infection medication that does not contain an antibiotic, the FDA said in its approval... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - March 19, 2024 Category: General Medicine Source Type: news

Cell therapy approach harnesses the immune system in a different way to stop cancer
A new cancer treatment that uses a person’s own immune cells has been approved by the U.S. Food and Drug Administration (FDA) for treating the most dangerous type of skin cancer. Now this form of cellular therapy (tumor-infiltrating lymphocyte - or TIL therapy) is showing promise in advanced lung cancers through clinical trials underway at The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC - James). (Source: World Pharma News)
Source: World Pharma News - March 19, 2024 Category: Pharmaceuticals Tags: Featured Research Research and Development Source Type: news

FDA Approves Expanded Generalized Pustular Psoriasis Indications for Spevigo
Ingelheim, Germany, March 19, 2024 -- Boehringer Ingelheim today announced that the US Food and Drug Administration (FDA) has approved Spevigo (spesolimab-sbzo) injection for the treatment of generalized pustular psoriasis (GPP) in adults and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 19, 2024 Category: Drugs & Pharmacology Source Type: news