Sarepta says eight-year-old death deemed unrelated to Elevidys
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Washington Post
37 minutes ago
- Washington Post
Vocal FDA critic who became top agency vaccine regulator abruptly departs
Vinay Prasad, a critic of broadly administering coronavirus shots who became the Food and Drug Administration's top vaccine regulator, has left his role months into his job. He's departing after coming under fire from some Republicans and conservative activists, including far-right activist Laura Loomer. The FDA division Prasad led had also been grappling with controversial decisions over how to handle deaths of patients who received a drug made by Sarepta Therapeutics to treat the rare genetic disease Duchenne muscular dystrophy. The Department of Health and Human Services confirmed that Prasad left the job but did not explain why. 'Dr. Prasad did not want to be a distraction to the great work of the FDA in the Trump administration and has decided to return to California and spend more time with his family,' Andrew Nixon, an HHS spokesman, said in a statement. 'We thank him for his service and the many important reforms he was able to achieve in his time at FDA.' Prasad, previously a University of California at San Francisco professor and epidemiologist, did not immediately return a request for comment. Loomer, who had successfully pushed for the ouster of national security officials in the Trump administration, recently turned on Prasad, describing him on her website as 'The Progressive Leftist Saboteur Undermining President Trump's FDA.' She was referring to his previous support for Democratic politicians. Before joining the Trump administration, Prasad gained prominence as a critic of the public health response to the coronavirus pandemic, including annual vaccination for children and vaccine mandates. In May, Prasad replaced Peter Marks, who championed the coronavirus shots, as the head of the FDA's Center for Biologics Evaluation and Research. Health Secretary Robert F. Kennedy Jr. forced Marks out in late March.
Time Business News
2 hours ago
- Time Business News
Where to Buy MK-677 in the USA: Top Trusted Sources
If you're looking for MK677 for sale in the USA, it's important to find a source that's both trusted and safe. MK-677, also known as Ibutamoren, is popular in the research world for its ability to boost growth hormone levels and support muscle development. But not all websites or sellers offer pure products. One well-known and reliable name in the industry is PureRawz, a company known for selling high-quality research compounds. In this guide, we'll explain how to find trustworthy places to buy MK-677 online, what to look for before buying, and why purity matters. MK-677 is a compound that acts like a growth hormone secretagogue. This means it helps the body release more growth hormone. It's not a steroid, but many researchers explore it for its effects on muscle mass, fat loss, and recovery. Some of the reported benefits from research use include: Increase in muscle mass Better recovery after workouts Improved sleep quality Reduced fat over time Higher levels of IGF-1 MK-677 is not approved by the FDA for medical use, but it is legal to buy for research purposes. That's why most vendors sell it with a 'for research only' label. So, if you're purchasing it, make sure you understand that it's not meant for personal or human use unless approved by your healthcare provider or part of a study. Since MK-677 is a research compound, it's not regulated like prescription drugs. This means the quality can vary from one seller to another. If you're not careful, you might end up with: A product that contains no active ingredient A fake or low-quality mix Harmful additives That's why choosing a trusted source is very important. You want the product to be pure, third-party tested, and come from a company with a good reputation. Here are some of the top websites where researchers often buy MK-677: PureRawz is one of the most popular and trusted names when it comes to SARMs and research chemicals. They offer MK677 for sale in different forms like liquid, capsules, and powder. Why choose PureRawz: Third-party lab tested Fast shipping in the USA Transparent about ingredients Good customer support Many researchers in the USA prefer PureRawz because they maintain high standards and have been around for a while. Note: was a trusted source but has paused sales. We recommend checking their official website for updates. Chemyo also offers a wide range of research compounds, including MK-677. They focus on quality and lab testing. Their products often come with a QR code that links to lab test results. Pros: High-quality packaging Strong customer base Verified purity Amino Asylum is a U.S.-based vendor known for research-grade products. While they have a wide range of compounds, make sure to confirm third-party lab testing before buying. Before you place an order, here are a few important things to check: Third-party lab testing: Always look for a certificate of analysis (COA) on the product page. Customer reviews: Check real reviews to see what others say about product quality. Clear labeling: The product should say 'for research use only' and include dosage details. Shipping policy: A good vendor should ship quickly and discreetly. Return or refund policy: A solid return policy shows that the company stands behind their product. MK-677 comes in different forms. The two most common are liquid and capsules. Liquid MK-677 is usually more affordable and easier to measure in smaller doses. But it may taste bitter. is usually more affordable and easier to measure in smaller doses. But it may taste bitter. Capsules are easier to use but might cost a little more. Your choice depends on your research needs and budget. Finding MK677 for sale in the USA doesn't have to be risky if you know where to look. Start with trusted names like PureRawz, Chemyo, or other established sources. Always make sure to check for third-party testing and reviews before buying. Don't go for the cheapest option—quality and purity matter most. Whether you're doing a study on muscle recovery or testing its effects on growth hormone levels, always buy from vendors that offer real, lab-tested products. That way, your research will stay accurate and safe. TIME BUSINESS NEWS
Business Upturn
2 hours ago
- Business Upturn
22nd Century Applauds the American Academy of Family Physicians Comments and Support of the FDA's Proposed Reduced Nicotine Mandate to Reduce Smoking, Transform Public Health, Save Lives and Reduce Health Costs
22nd Century VLN ® products are the only combustible cigarettes authorized by the FDA as a reduced nicotine content product that comply with the FDA proposed rule MOCKSVILLE, N.C., July 29, 2025 (GLOBE NEWSWIRE) — 22nd Century Group, Inc. (Nasdaq: XXII), the only tobacco products company that has for 27 years led and continues to lead the fight against the harms of smoking driven by nicotine addiction, today commented on responses provided to the U.S. Food and Drug Administration to date as part of its open comment period on the proposed new Tobacco Product Standard for Nicotine Yield of Cigarettes and Certain Other Combusted Tobacco Products . 'In the United States, smoking causes more than 480,000 deaths and costs over $600 billion annually and reduces life expectancy by 10 years. The US government and our federal courts have issued countless warnings concerning nicotine, the effects of nicotine addiction, and the harms caused by smoking since the early 1950's. Implementation of the proposed FDA standard, which would require that all combusted tobacco products sold in the U.S. contain less than 0.7mg of nicotine per gram of tobacco, would directly combat the public health issues resulting from nicotine and nicotine dependence, as outlined by the American Academy of Family Physicians,' said Larry Firestone, Chief Executive Officer of 22nd Century Group. Comments published from the American Academy of Family Physicians (AAFP), which represents more than 128,300 family physicians and medical students across the country, recommend the FDA finalize the proposed mandate as the new standard, including: Establishing a maximum nicotine yield of 0.7 milligrams per gram of total tobacco in cigarettes and other combusted tobacco products Extending the standard to other forms of nicotine consumption, such as e-cigarettes and vapes, as a means to protect children and support quitting. It's letter states: 'Establishing a maximum nicotine yield is a vital step towards curbing nationwide tobacco dependence.' The full comment submission can be read on the AAFP webpage found here . 'The commercial launch of our low nicotine VLN® products which include partner brand products such as Smoker Friendly VLN® and Pinnacle VLN®, demonstrate the commercial viability for cigarettes which are already compliant with the new standard. If licensed from, or produced by 22nd Century, VLN® products can be quickly produced, marketed and sold under the wide array of brands in the tobacco industry,' said Larry Firestone, Chief Executive Officer of 22nd Century Group. About 22nd Century Group, Inc. 22nd Century Group is the pioneering nicotine harm reduction company in the tobacco industry enabling smokers to take control of their nicotine consumption. We created our flagship product, the VLN® cigarette, to give traditional cigarette smokers an authentic and familiar alternative in the form of a combustible cigarette that helps them take control of their nicotine consumption. VLN® cigarettes have 95% less nicotine than the traditional cigarette and have been proven to allow consumers to greatly reduce their nicotine consumption. Instead of offering new ways of delivering nicotine to addicted smokers, we offer smokers in the form that they are used to, the option to take control of their nicotine consumption and make informed and more productive choices, including the choice to avoid addictive levels of nicotine altogether. Our proprietary non-GMO reduced nicotine tobacco blends are made possible by comprehensive and patented technologies and tobacco plants that regulate nicotine biosynthesis activities in the tobacco plant, resulting in full flavor and high yield with 95% less nicotine. Our extensive patent portfolio has been developed to ensure we have the only low nicotine combustible cigarette in the United States and critical international markets. VLN® is a registered trademark of 22nd Century Limited LLC. Learn more at , on X (formerly Twitter) , on LinkedIn , and on YouTube . Learn more about VLN® at Cautionary Note Regarding Forward-Looking Statements Except for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements, including but not limited to our full year business outlook. Forward-looking statements typically contain terms such as 'anticipate,' 'believe,' 'consider,' 'continue,' 'could,' 'estimate,' 'expect,' 'explore,' 'foresee,' 'goal,' 'guidance,' 'intend,' 'likely,' 'may,' 'plan,' 'potential,' 'predict,' 'preliminary,' 'probable,' 'project,' 'promising,' 'seek,' 'should,' 'will,' 'would,' and similar expressions. Forward-looking statements include, but are not limited to, statements regarding (i) our cost reduction initiatives, (ii) our expectations regarding regulatory enforcement, including our ability to receive an exemption from new regulations, (iii) our financial and operating performance and (iv) our expectations for our business interruption insurance claim. Actual results might differ materially from those explicit or implicit in forward-looking statements. Important factors that could cause actual results to differ materially are set forth in 'Risk Factors' in the Company's Annual Report on Form 10-K filed on March 20, 2025 and Quarterly Report on Form 10-Q filed on May 13, 2025. All information provided in this release is as of the date hereof, and the Company assumes no obligation to and does not intend to update these forward-looking statements, except as required by law. Investor Relations & Media ContactMatt KrepsInvestor Relations22nd Century Group [email protected] 214-597-8200
