by Ernie Mundell People threatened by accidental exposure to foods they’re allergic to may have a new weapon of defense: On Feb. 16, the U.S. Food and Drug Administration expanded the use of the asthma drug Xolair to help prevent anaphylactic reactions. Xolair (omalizumab) is an injected drug and is not meant as a substitute...
The US Food and Drug Administration (FDA) has cleared NM-101 (Terran Biosciences), a cloud-based software platform to analyze neuromelanin-sensitive MRI scans, which could aid in the diagnosis of neurodegenerative diseases. Research has suggested that neuromelanin is a potential biomarker for neurologic disorders such as Parkinson’s disease (PD). A recent meta-analysis of 12 neuromelanin MRI studies...
By Meg Tirrell, CNN Since Johnny Lubin got the exa-cel treatment in October 2021, “he’s been like a normal child,” his mother says. “It’s life-changing for us.”Courtesy JR Lubin and Fabienne DesirCNN — Before Johnny Lubin got a potentially life-changing experimental treatment at the age of 13, he recalls, he had one main concern. “I was...
by Sarah Gantz, The Philadelphia Inquirer Hodgkin lymphoma, nodular lymphocyte predominant (high-power view) Credit: Gabriel Caponetti, MD./Wikipedia/CC BY-SA 3.0 The University of Pennsylvania plans to continue offering CAR-T therapy, a cancer treatment pioneered at Penn, after the Food and Drug Administration announced an investigation into whether the treatment may cause cancer in rare cases. Chimeric...
by Lori Solomon The U.S. Food and Drug Administration has approved Takeda Pharmaceuticals Adzynma, the first recombinant protein product indicated for prophylactic or on-demand enzyme replacement therapy (ERT) in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP). Adzynma is a purified recombinant form of the ADAMTS13 enzyme that enhances the low levels of...
Miriam E. Tucker November 07, 2023 The US Food and Drug Administration (FDA) has warned against the use of an over-the-counter product called “Dr. Ergin’s SugarMD Advanced Glucose Support” because it was found to contain the prescription glucose-lowering medications metformin and glyburide. The product was sold on the website www.sugarmds.com and was promoted for blood glucose management....
by Physician’s Briefing Staff A new gene therapy for sickle cell disease has been deemed safe by a U.S. Food and Drug Administration advisory panel, paving the way for full approval by early December 2023. The FDA had already decided that the therapy, known as exagamglogene autotemcel (exa-cel), was effective. Developed by Vertex Pharmaceuticals of...
News brief October 24, 2023 Lisa Schnirring AstraZeneca today announced that the US Food and Drug Administration (FDA) has agreed to review its application for the option for its FluMist flu vaccine to be self- or caregiver-administered, which if approved will be the first vaccine available for self-administration or by caregivers, offering another option for...
Faced with growing reports of inaccurate clinical lab tests, the U.S. Food and Drug Administration on Friday announced that it will for the first time regulate these vital diagnostic tools. “A growing number of clinical diagnostic tests are being offered as laboratory developed tests without assurance that they work. The stakes are getting higher as...
From Meridian Bioscience, Inc.Meridian Bioscience, Inc., a leading global provider of diagnostic testing solutions and life science raw materials, announced today that the United States Food and Drug Administration (FDA) had granted clearance for the company’s new Curian® Shiga Toxin assay. This assay joins Curian HpSA® and Curian Campy as Meridian expands its Curian diagnostic...
