FDA
[Research Articles] Spontaneous reversal of stenosis in tissue-engineered vascular grafts  Science Magazine · 3 days
We developed a tissue-engineered vascular graft (TEVG) for use in children and present results of a U.S. Food and Drug Administration (FDA)–approved clinical trial evaluating this graft in... more
FDA wants heartburn meds off the market due to contamination  ABC NEWS · 3 days
The U.S. Food and Drug Administration is telling drugmakers to immediately pull a type of heartburn drug off the market due to contamination with a chemical that may... more
FDA to trial malaria drugs Chloroquine and Hydroxychloroquine for COVID-19  NEWS MEDICAL · 4 days
The U.S. Food and Drug Administration (FDA) this week provided the necessary authorization for clinical trials of chloroquine and hydroxychloroquine for the treatment of the novel coronavirus. These... more
FDA nod for first experimental plasma therapy for COVID-19 in the U.S.  NEWS MEDICAL · 4 days
The coronavirus disease (COVID-19) global pandemic has rapidly spread across the globe, now affecting 180 countries and territories. The United States is the front... more
FDA changes boost alcohol for sanitizer from ethanol makers  ABC NEWS · 4 days
The Food and Drug Administration has relaxed regulations on the types of alcohol that can be used for hand sanitizer during a shortage caused by high demand from the coronavirus... more
What takes so long? A behind-the-scenes look at the steps involved in COVID-19 testing  NEWS MEDICAL · 6 days
After a slow start, testing for COVID-19 has ramped up in recent weeks, with giant commercial labs jumping into the... more
The Latest: FDA clears test that can quickly detect virus  ABC NEWS · 1 week
The U.S. Food and Drug Administration has cleared a new rapid test from Abbott Laboratories, which the company says can detect the coronavirus in about 5 minutes more
The Latest: US eases regulations on medical equipment  ABC NEWS · 1 week
The U.S. Food and Drug Administration says hospitals can repurpose medical equipment, including devices used to treat sleep apnea, to serve as ventilators amid concerns about the national supply of the life-sustaining... more
Existing FDA-Approved Drugs Could Help Fight COVID-19 Disease  SCI-NEWS.COM · 1 week
Drugs that are already approved by the U.S. Food and Drug Administration (FDA) could hold promise in fighting COVID-19, a... more
FDA approves immune-modulating therapy for treatment of multiple sclerosis  NEWS MEDICAL · 1 week
The U.S. Food and Drug Administration has approved ozanimod, an immune-modulating therapy invented at Scripps Research, for the treatment of adults with relapsing forms of multiple sclerosis. more
FDA provides emergency use authorization to PerkinElmer for COVID-19 testing  NEWS MEDICAL · 1 week
PerkinElmer, Inc., a global leader committed to innovating for a healthier world, announced today that the U.S. Food and Drug Administration (FDA) has provided Emergency Use Authorization (EUA)... more
Malfunctioning EpiPens could harm patients, companies say  ABC NEWS · 2 weeks
The U.S. Food and Drug Administration is warning the public about dangerous malfunctions involving a limited number of EpiPens, the emergency injectors for severe allergic reactions more
Gilead's potential coronavirus treatment gets FDA's orphan drug label  REUTERS · 2 weeks
Gilead Sciences Inc's experimental drug remdesivir, seen as one of the more promising potential treatments for the coronavirus,... more
C-Path awarded FDA grant to establish Rare Disease Clinical Outcome Assessment Consortium  NEWS MEDICAL · 2 weeks
The U.S. Food and Drug Administration's Center for Drug Evaluation and Research has funded a cooperative agreement to establish a Rare Disease Clinical Outcome... more
Organ-Chips provide human-relevant insights into diseases and toxicity mechanisms  NEWS MEDICAL · 2 weeks
Organs-on-Chips technology has entered the mainstream and has reached 150 installations for use by researchers across many industries, including 10 of the top 25 biopharmaceutical companies, as well as leading... more
Engineered Botulinum toxin is more potent and safer in mice  SCIENCE DAILY · 3 weeks
Botulinum toxin (BoNT) is used for a range of applications, but when injected it can diffuse into the surrounding tissue and give rise to adverse effects. A new... more
Engineered botox found to be more potent and safer in mice  NEWS MEDICAL · 3 weeks
A team has reduced negative side effects of FDA-approved form of Botulinum toxin by enhancing binding to nerve cells. more
EKF launches FDA CLIA-waived β-ketone and glucose POC analyzer to U.S. market  NEWS MEDICAL · 3 weeks
EKF Diagnostics, the global in vitro diagnostics company, announces a new addition to its Diabetes Care portfolio in the U.S.. The STAT-Site WB is... more
Citing virus, US halts inspections of foreign drug plants  ABC NEWS · 4 weeks
The Food and Drug Administration is halting most inspections of overseas plants that ship drugs, medical equipment and other goods to the U.S. amid the growing coronavirus outbreak more
Investigational CAR-T therapy for Hodgkin lymphoma receives fast-track designation from FDA  NEWS MEDICAL · 4 weeks
Based on proof-of-concept results from clinical trials at University of North Carolina Lineberger Comprehensive Cancer Center and Baylor College of Medicine, an investigational cellular immunotherapy for... more
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