All posts tagged: FDA

FDA Approves Futuristic Gel That Can Stop Life-Threatening Bleeding in Seconds

FDA Approves Futuristic Gel That Can Stop Life-Threatening Bleeding in Seconds

Published by José

The US Food and Drug Administration has approved a futuristic gel that can stop severe bleeding from life-threatening injuries, like a deep cut or gunshot wound, for human use. As Reuters reports, the invention could represent a big leap, providing first responders a way to treat major wounds in a matter of seconds. The gel dubbed Traumagel was developed by Cresilon, a medical device company based in Brooklyn. “This is for stab wounds, gunshot wounds, motor vehicle accidents — really anywhere where this product will stand between a patient and death,” Cresilon CEO Joe Landolina told Reuters. Current methods that use tourniquets, gauze wraps, or chemicals can take a relatively long time to stem the bleeding, unlike Traumagel which can effectively patch a life-threatening injury in seconds, according to Landolina. Traumagel, an algae-derived product, comes in a syringe, is ready for use, and is easy to apply. Landolina told Reuters the product will be commercially available in late 2024, and envisions the gel being used by paramedics and combat medics out in the field. “91 …

FDA announces that eating yogurt can help prevent type 2 diabetes

FDA announces that eating yogurt can help prevent type 2 diabetes

Published by skeptic

The FDA found credible evidence suggesting that yogurt consumption could be associated with a reduced risk of type 2 diabetes. (CREDIT: Creative Commons) The U.S. Food and Drug Administration (FDA) has recently issued a statement regarding the potential health benefits of yogurt, particularly in relation to reducing the risk of type 2 diabetes. This announcement follows the evaluation of a petition by Danone North America, advocating for health claims that link regular yogurt consumption with a decreased likelihood of developing this chronic condition. Health claims on food labels are tools used by manufacturers to inform consumers about potential health benefits related to their products. These claims must be grounded in scientific evidence and are categorized into two types: authorized health claims and qualified health claims. Authorized claims require robust evidence and consensus within the scientific community, while qualified claims are supported by preliminary evidence but do not meet the stringent criteria of significant scientific agreement. In its review of the evidence provided by Danone and other relevant studies, the FDA found credible but limited evidence …

No One Knows How Far Bird Flu Has Spread

No One Knows How Far Bird Flu Has Spread

Published by skeptic

In late March, the US Department of Agriculture (USDA) announced it had detected cases of bird flu in dairy cattle. Initially discovered in dairy farms in Texas, Kansas, and New Mexico, there are now 36 confirmed outbreaks in dairy herds in nine states. Although the H5N1 virus circulates widely in wild birds, it is now circulating among dairy cattle in the US. The USDA has confirmed transmission between cows in the same herd, from cows to birds, and between different dairy cattle herds. But the reported outbreaks are likely to be a major underestimation of the true spread of the virus, says James Wood, head of veterinary medicine at the University of Cambridge. “It’s likely there is going to be a fair amount of underreporting and underdiagnosis,” he says. Tests by the Food and Drug Administration (FDA) of retail milk samples might give some indication of how widespread the virus is. The agency found viral fragments in one in five samples of commercial milk, although this virus had been deactivated by pasteurization so was not …

Apple Watch AFib History Feature Qualified by FDA to Evaluate Medical Devices

Apple Watch AFib History Feature Qualified by FDA to Evaluate Medical Devices

Published by skeptic

Apple’s atrial fibrillation (AFib) history feature on Apple Watch has been qualified by the FDA under its Medical Device Development Tools (MDDT) program, the first digital health technology feature of its kind to do so. Since 2022, Apple Watch has supported AFib History, which allows users diagnosed with atrial fibrillation to view an estimate of how frequently their heart is in this type of irregular rhythm. The feature analyzes pulse rate data collected by a photoplethysmography (PPG) sensor to identify episodes consistent with AFib and provides the user with a retrospective estimate of AFib burden (a measure of the amount of time spent in AFib during past Apple Watch wear). Apple says the feature is intended for individuals aged 22 years or older who have been diagnosed with atrial fibrillation. The AFib History feature received FDA clearance in the United States just prior to its announcement by Apple, after being validated in a clinical study. The MDDT program under which the feature was approved today is the FDA’s method of qualifying tools that medical device …

To save lives, the FDA must change how it evaluates rare disease treatments

To save lives, the FDA must change how it evaluates rare disease treatments

Published by skeptic

There are over 7,000 rare diseases that collectively affect more than 30 million Americans. Children and families struggling with these diseases need treatments — and hope. We’re urging the U.S. Food and Drug Administration to use regulatory tools, such as its accelerated approval pathway, to speed up the development and approval of treatments. But to date, FDA regulators haven’t done so, even for promising drug candidates. We are regrettably well-acquainted with one of these disease groups: a class of genetic metabolic conditions called the mucopolysaccharidoses, or MPSs. One of us — Mark Dant — has a child born with an MPS disorder. Dr. Matthew Ellinwood, a translational researcher and the chief scientific officer at the National MPS Society, has spent his career researching MPS. The MPSs typically arise in infancy and early childhood. The 12 MPS subtypes cumulatively affect one in every 25,000 children. They cause developmental delay, chronic pain, enlarged organs and early death in severe cases. Sadly, countless other rare disease patients are in a similar predicament. Regulators rarely approve promising treatments without …

FDA Update on Bird Flu Traces in Milk: What to Know About Pasteurized and Raw Milk

FDA Update on Bird Flu Traces in Milk: What to Know About Pasteurized and Raw Milk

Published by skeptic

Fragments of the virus that causes bird flu, H5N1, were found in one in five pasteurized milk samples across the US, the US Food and Drug Administration announced Thursday. A day later, the agency posted an update with good news, confirming that additional testing of the samples didn’t turn up active or infectious virus, which is what experts have said would be the case since pasteurization is expected to kill or inactivate bird flu virus, as it does other potentially harmful bacteria and viruses.  The FDA says the milk supply remains safe; pasteurization is a requirement for commercial milk, making up the vast majority of milk found on store shelves (though not all, depending on local laws around raw milk sales).  Still, the announcement about evidence of virus in pasteurized milk was jarring because since bird flu was first reported in US dairy cows, evidence of it had only previously been reported in unpasteurized product, which hasn’t gone through the process of heating milk to get rid of viruses and bacteria like pasteurized products have. It also suggested …

US commercial milk supply safe despite discovery of bird flu virus fragments

US commercial milk supply safe despite discovery of bird flu virus fragments

Published by skeptic

The U.S. Food and Drug Administration said this week that about one in five U.S. commercial milk samples from a nationwide survey contained traces of bird flu virus, but it maintained that the product remains safe to consume. The public health risk posed by the H5N1 bird flu pathogen is minimal, the World Health Organization said Friday, adding that countries should remain vigilant and work to reduce exposure. The FDA said late Thursday that additional testing was required to determine whether a live virus was still intact in the milk samples but added that there was currently no evidence that the milk posed a danger. The U.S. Department of Agriculture and the FDA said that pasteurization used in production makes the milk safe for consumption, as it heats the milk to a specific temperature to kill harmful bacteria and viruses. Further, milk from sick cows gets diverted or destroyed in the pasteurization process. The FDA said in its latest update that “to date, the retail milk studies have shown no results that would change our …

1 in 5 samples of pasteurized milk contained virus fragments, FDA finds

1 in 5 samples of pasteurized milk contained virus fragments, FDA finds

Published by skeptic

The Food and Drug Administration said Thursday that traces of the bird flu virus have been found in 1 in 5 samples of pasteurized milk, providing a more detailed picture of how much of the milk supply has been affected. The tested milk came from a nationally representative sample, with more of the positive results coming from milk in areas with infected herds of dairy cows, the FDA said. A spokesperson declined to say how many samples were tested. As of Thursday, bird flu had been detected in 33 herds in eight states: Idaho, Kansas, Michigan, New Mexico, North Carolina, South Dakota, Ohio and Texas. Richard Webby, an influenza virologist at St. Jude Children’s Research Hospital, said the number of positive samples is consistent with numbers he’s reviewed from smaller sample sets. “But the number does seem high if the number of infected farms is indeed only 30-odd,” Webby wrote in an email. “Clearly there are more infected animals out there than being reported.” The FDA first said Tuesday that it had found viral fragments …

Bird flu virus remnants found in pasteurized milk, FDA says

Bird flu virus remnants found in pasteurized milk, FDA says

Published by skeptic

The U.S. Food and Drug Administration said Tuesday, April 23, 2024, that samples of pasteurized milk had tested positive for remnants of the bird flu virus that has infected dairy cows. Rich Pedroncelli/AP hide caption toggle caption Rich Pedroncelli/AP The U.S. Food and Drug Administration said Tuesday, April 23, 2024, that samples of pasteurized milk had tested positive for remnants of the bird flu virus that has infected dairy cows. Rich Pedroncelli/AP The U.S. Food and Drug Administration said Tuesday that samples of pasteurized milk had tested positive for remnants of the bird flu virus that has infected dairy cows. The agency stressed that the material is inactivated and that the findings “do not represent actual virus that may be a risk to consumers.” Officials added that they’re continuing to study the issue. “To date, we have seen nothing that would change our assessment that the commercial milk supply is safe,” the FDA said in a statement. The announcement comes nearly a month after an avian influenza virus that has sickened millions of wild and …

FDA approves ImmunityBio’s bladder cancer treatment

FDA approves ImmunityBio’s bladder cancer treatment

Published by skeptic

The Food and Drug Administration has approved a new treatment for patients with bladder cancer that does not respond well to standard therapy. The treatment, which will be sold under the brand name Anktiva, is an immunotherapy agent designed to prompt the body’s immune system to step up its fight against cancer cells in the bladder. In a clinical trial led by UCLA, patients who responded to the treatment were much less likely to require surgery to remove all or part of their bladders than were patients who weren’t helped by the drug. The drug was approved Monday and is being developed by ImmunityBio of Culver City after its initial development by Altor BioScience of Miramar, Fla. ImmunityBio designed and sponsored the clinical trial that led to the FDA’s action. Dr. Patrick Soon-Shiong, whose family owns the Los Angeles Times, is executive chairman of ImmunityBio. In a statement, Soon-Shiong heralded the FDA action and called Anktiva “a next-generation immunotherapy.” The drug itself is designed to mimic a type of cell that causes the immune system …