by Lori Solomon The U.S. Food and Drug Administration has approved an additional indication for AstraZeneca’s Fasenra (benralizumab) as an add-on maintenance treatment for patients aged 6 to 11 years with severe asthma and an eosinophilic phenotype. This indication was supported by evidence from the Phase III TATE trial, as well as data from additional...
Alicia Ault Nearly 18 months after the US Food and Drug Administration (FDA) first acknowledged a national shortage of Adderall, the most common drug used to treat attention-deficit/hyperactivity disorder (ADHD), there is now a widespread scarcity of other stimulant medications — with no end in sight. How did this crisis develop and what measures are...
by Dennis Thompson When settling into your senior years, you need to be especially careful when taking medicines, herbal remedies and supplements, the U.S. Food and Drug Administration says. That’s because older adults are likely to use more prescription and over-the-counter medications, which increases the risk of harmful side effects and drug interactions, the FDA...
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...
