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.

Moderna says FDA delayed RSV vaccine approval to end of May
Moderna on Friday said the Food and Drug Administration has delayed the approval of its vaccine for respiratory syncytial virus to the end of May due to "administrative constraints" at the agency. The FDA was expected to make a decision on the RSV shot on Sunday. The agency has not informed…#fda #rsv #moderna #pfizer #gsk #cdc #stephenhoge #rna (Source: Reuters: Health)
Source: Reuters: Health - May 10, 2024 Category: Consumer Health News Source Type: news

How to Stop Bird Flu from Becoming the Next Pandemic
If H5N1 turns into a full-blown pandemic, we are currently in chapter one. To prevent chapter two from becoming a reality, the most important tool in our arsenal will be widespread testing. Testing isn’t just about diagnosing people with the virus. Containing the spread of this highly pathogenic bird flu strain in cattle hinges on our ability to detect and track it. The H5N1 outbreak in dairy cows is widespread and spans multiple U.S. states. Although only one human infection with the virus has been documented, more infections are likely going undetected. Most importantly, unchecked transmission among cattle mean...
Source: TIME: Health - May 9, 2024 Category: Consumer Health News Authors: Michael Mina and Janika Schmitt Tags: Uncategorized healthscienceclimate Source Type: news

More Than 200 Insulin Pump Users Injured After App Causes Malfunction
THURSDAY, May 9, 2024 -- The U.S. Food and Drug Administration has issued a Class 1 recall -- its most urgent kind -- for an IOS app linked to a specific kind of insulin pump used by people with diabetes. The recall notice, which the FDA says is a... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - May 9, 2024 Category: General Medicine Source Type: news

Scientists Are Finding Out Just How Toxic Your Stuff Is
If you are newly suspicious about the safety of the products in your medicine cabinet, there’s a good chance you have Valisure, a tiny laboratory in New Haven, Conn., to thank. Or blame. Tucked away in an unassuming office park, Valisure’s team of about a dozen scientists has over the past five years detected potentially cancer-causing chemicals in widely used medications, hand sanitizers, sunscreens, antiperspirant body sprays, dry shampoos, and—most recently—acne treatments. When Valisure sounds the alarm about a new scary-sounding finding, a flood of headlines, lawsuits, and product recalls o...
Source: TIME: Health - May 9, 2024 Category: Consumer Health News Authors: Jamie Ducharme Tags: Uncategorized feature healthscienceclimate Source Type: news

What ’ s the Best Kind of Sunscreen?
Sunscreen is a $10 billion business, with a seemingly endless array of products available for sale. Walk into your local drugstore and you’ll find chemical and mineral formulas in virtually every SPF count and format imaginable, from creams to sprays to sticks. So which one should you throw in your beach bag this summer? Here’s how to choose the right sunscreen, according to dermatologists. [time-brightcove not-tgx=”true”] What’s the difference between chemical and mineral sunscreens? There are two major types of sunscreen: chemical and mineral (also known as physical) formulas. The...
Source: TIME: Health - May 9, 2024 Category: Consumer Health News Authors: Jamie Ducharme Tags: Uncategorized Evergreen healthscienceclimate Source Type: news

Severe drug-induced liver injury due to self-administration of the veterinary anthelmintic medication, fenbendazole - Thakurdesai A, Rivera-Matos L, Nagra N, Busch B, Mais DD, Cave MC.
Fenbendazole is an anthelmintic agent approved for veterinary applications. Even though it is not approved by the US Food and Drug Administration for human use, such use appears to be increasing due to the popularization of fenbendazole's potential antican... (Source: SafetyLit)
Source: SafetyLit - May 9, 2024 Category: International Medicine & Public Health Tags: Alcohol and Other Drugs Source Type: news

ACR responds to Congressional query on AI reimbursement
American College of Radiology (ACR) CEO William Thorwarth Jr., MD, issued a nine-page letter to Congress recommending how to solve the reimbursement problem for AI in healthcare and ensure clinical AI is of value to patients and health systems. Thorwarth's response is just one prompted by a March 20 request from the Bipartisan House Task Force on Artificial Intelligence (AI), led by U.S. Rep. Ami Bera, MD, (D-CA). Among the key questions posed by Bera is, "What measures can be employed to guarantee proper reimbursement and coverage for AI technologies in healthcare?" Among other healthcare specialties, radiology has been...
Source: AuntMinnie.com Headlines - May 9, 2024 Category: Radiology Authors: Liz Carey Tags: Artificial Intelligence Regulatory Administration Source Type: news

FDA issues final guidance clarifying'remanufacturing' for devices
The U.S. Food and Drug Administration (FDA) has issued final guidance to provide the medical device industry clarity on the definition of "remanufacturing" for reusable devices needing maintenance or repair. The final guidance seeks to ensure consistency regarding what constitutes remanufacturing activities and to promote a better understanding of applicable federal law and regulations implicated by remanufacturing activities. It was issued following the agency's review of postmarket information and consideration of public comments. These highlighted the need for clarity, considering the different regulatory implication...
Source: AuntMinnie.com Headlines - May 9, 2024 Category: Radiology Authors: AuntMinnie.com staff writers Tags: Industry News Source Type: news

Zydus Lifesciences gets USFDA approval for generic acne treatment gel
Zydus Lifesciences Ltd received final approval from the US Food and Drug Administration (USFDA) to market its generic version of Dapsone gel 7.5% for acne treatment. The gel is manufactured at their facility in Ahmedabad. Dapsone gel 7.5% had annual sales of $35.8 million in the US, according to IQVIA MAT March 2024 data, as reported in a regulatory filing. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - May 9, 2024 Category: Pharmaceuticals Source Type: news

RFK Jr. Says He Had a Brain Parasite. Here ’ s How That Can Happen
Presidential candidate Robert F. Kennedy Jr. said he suffered memory loss and severe brain fog more than a decade ago, potentially related to a parasite in his brain, according to the New York Times. In a 2012 deposition reviewed by the Times, Kennedy said a worm “got into my brain and ate a portion of it and then died.” He said the cognitive issues later resolved. Around the same time, the Times reports, Kennedy was also diagnosed with mercury poisoning, which can also result in cognitive issues. [time-brightcove not-tgx=”true”] Though they sound like something straight out of a horror movie...
Source: TIME: Health - May 8, 2024 Category: Consumer Health News Authors: Jamie Ducharme Tags: Uncategorized healthscienceclimate Source Type: news

Samsung Medison to acquire Sonio
Korea-based Samsung Medison has signed an agreement to acquire French startup and fetal ultrasound AI software developer Sonio. Sonio will remain an independent company headquartered in France, according to Samsung Medison, and will continue its commercial growth independently while its products and services will remain compatible with all ultrasound device makers. The company's flagship product, Sonio Detect, received U.S. Food and Drug Administration (FDA) 510(k) clearance for analysis of prenatal ultrasound exams in August 2023. Established in 2020, Sonio also announced in August 2023 that it had raised $14 million in...
Source: AuntMinnie.com Headlines - May 8, 2024 Category: Radiology Authors: AuntMinnie.com staff writers Tags: M&A Source Type: news

Eating yogurt could help prevent this serious disease: FDA
Can incorporating yogurt into your diet keep diabetes at bay? The U.S. Food and Drug Administration (FDA) has implied that it’s possible. The health agency announced in March that it will not object to a claim from Danone North America — maker of Dannon and other popular yogurt brands — that…#fda #danonenorthamerica #dannon #sherrycolemancollins #atlanta #foxnewsdigital #plain #greek (Source: Reuters: Health)
Source: Reuters: Health - May 8, 2024 Category: Consumer Health News Source Type: news

Eating yogurt could help prevent one common disease, according to the FDA
Can incorporating yogurt into your diet keep ? The U.S. Food and Drug Administration (FDA) has implied that it’s possible. The health agency announced in March that it will not object to a claim from Danone North America — maker of Dannon and other popular yogurt brands — that regularly eating…#fda #danonenorthamerica #dannon #sherrycolemancollins #utah #foxnewsdigital (Source: Reuters: Health)
Source: Reuters: Health - May 8, 2024 Category: Consumer Health News Source Type: news

Startup that raised over $100M gets FDA approval for cancer test
St. Louis gastrointestinal health startup Geneoscopy has received U.S. Food and Drug Administration approval for the screening test it has developed to detect colorectal cancer. (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - May 8, 2024 Category: Pharmaceuticals Authors: Nathan Rubbelke Source Type: news

FDA Roundup: May 7, 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 - May 7, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news