Today, the U.S. Food and Drug Administration is providing an update on its multipronged response to monkeypox in the United States, including its efforts in the areas of diagnostics, vaccines and therapeutics. The agency has also established a dedicated website to provide important information about the FDA’s ongoing regulatory activities related to monkeypox along with frequently asked questions. The FDA will provide updates as developments occur and will continue to work with federal public health partners and industry to ensure timely access to all available medical countermeasures.
“The FDA has been closely tracking reports of monkeypox transmissions in the United States with our federal public health partners and coordinating preparedness efforts accordingly,” said FDA Commissioner Robert M. Califf, M.D. “We understand that while we are still living with COVID-19, an emerging disease may leave people feeling concerned and uncertain, but it’s important to note that we already have medical products in place, specifically an FDA-approved vaccine for the prevention of monkeypox disease and an FDA-cleared diagnostic test. The FDA is using the full breadth of its authorities to make additional diagnostics and treatments available. We will continue to collaborate with our partners across all sectors to expand accessibility to countermeasures and bolster the tools in our arsenal as appropriate.”
The monkeypox virus is part of the same family of viruses as variola virus, the virus that causes smallpox (a virus that has been eradicated globally). Both monkeypox and smallpox fall into the category of “orthopoxviruses.” Monkeypox is generally not fatal and typically resolves on its own without treatment. The current outbreak in the U.S. usually presents as a rash on the body, face or genital area. Although there is a very low risk of dying, there have been reported complications including severe pain, at times requiring hospital admission.
Diagnostics
Since the first case of monkeypox in the U.S. was detected, the FDA has been working with commercial laboratories and manufacturers to make monkeypox tests more readily available to consumers who need them. The Centers for Disease Control and Prevention (CDC) has an FDA-cleared non-variola orthopoxvirus test that can detect monkeypox by a swab from a monkeypox lesion (rash or growth). At this time, this is the only FDA-cleared test. The FDA is not aware of clinical data supporting the use of other sample types, such as blood or saliva, for monkeypox virus testing. In July 2022, the FDA issued a safety communication advising people to use swab samples taken directly from a lesion when testing for the monkeypox virus.
The FDA-cleared monkeypox test is being offered by the CDC and throughout many laboratories that include the CDC’s public health Laboratory Response Network. In addition, federal public health authorities have worked with industry to make the test available through five large commercial laboratories. The agency is working closely with the CDC to increase production of its FDA-cleared test and the FDA has cleared the use of additional reagents and instruments to increase the throughput of the CDC test.
The FDA will continue to work with the diagnostic community to augment access to accurate testing to support the response.
Vaccines
In 2019, the FDA approved the JYNNEOS Vaccine for the prevention of smallpox and monkeypox in adults 18 years of age and older determined to be at high risk of infection. JYNNEOS is the only vaccine approved for the prevention of monkeypox in the United States. Although clinical trials and data are limited because of the small number of cases until now, the immunological response to vaccine administration is consistent with effective prevention of the disease.
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Following the emerging public health crisis closely, the FDA was aware that there were close to 800,000 doses of this vaccine pending release this fall following approval of additional manufacturing capabilities at one of the plants where the vaccine is made. With this in mind, the agency worked with HHS partners and expedited the submission of the required application for the company’s manufacturing changes in order to make these doses available to those in need. After accelerating the timeline for an inspection of the plant from fall to earlier this month, the FDA has finished its evaluation of the required information to validate product quality and has determined that the vaccine meets its quality standards.
On July 26, the agency approved a supplement to the biologics license for the JYNNEOS Vaccine, to allow for additional manufacturing capabilities at the facility. Given the emerging public health need, the FDA previously facilitated the shipment of manufactured doses to the U.S. so that they would be ready to be distributed once the manufacturing changes were approved. With the supplement approval, those manufactured doses may now be further distributed and administered. Additional doses manufactured at this plant can help address the need for this vaccine moving forward.
Therapeutics
There is no FDA-approved or authorized medicine for the treatment of monkeypox disease; however, TPOXX (tecovirimat), an antiviral medication, is being made available through the CDC under an FDA authority called Expanded Access or “compassionate use.” The FDA continues to work with the CDC to streamline their Expanded Access Program for monkeypox to facilitate access.
There are currently no human data demonstrating the efficacy of TPOXX for the treatment of monkeypox, or the safety and pharmacokinetic profile (which helps us understand what the human body does to a drug). Although expanded access program is available, conducting randomized, controlled trials to assess TPOXX’s safety and efficacy in humans with monkeypox infections is essential.
The FDA has more information on TPOXX’s approval for smallpox under the “Animal Rule” regulations on its monkeypox webpage.
Rod: A creative force, blending words, images, and flavors. Blogger, writer, filmmaker, and photographer. Cooking enthusiast with a sci-fi vision. Passionate about his upcoming series and dedicated to TNC Network. Partnered with Rebecca Washington for a shared journey of love and art. View all posts
Rod: A creative force, blending words, images, and flavors. Blogger, writer, filmmaker, and photographer. Cooking enthusiast with a sci-fi vision. Passionate about his upcoming series and dedicated to TNC Network. Partnered with Rebecca Washington for a shared journey of love and art.
Swisse Launches Glam Bites: Zero-Sugar Beauty Gummies Designed for Busy Routines
Swisse launches Glam Bites: delicious beauty gummies with zero sugar, no sugar alcohols, and no artificial flavors, colors, or sweeteners—designed to support beauty from within.
Swisse Launches Glam Bites: Zero-Sugar Beauty Gummies Designed for Busy Routines
Swisse, the premium supplement brand under Health & Happiness (H&H) Group and a Certified B Corp, is kicking off 2026 with a new way to support “beauty from within.” The company just introduced Swisse Beauty Glam Bites, a line of zero-sugar beauty gummies made with science-backed ingredients—without the usual “junk” found in many gummy supplements. Positioned for today’s always-on lifestyle, Glam Bites aims to make daily self-care feel less like another task and more like a quick, enjoyable habit: bite, nourish, and glow.
What makes Glam Bites different?
Gummy supplements are popular, but they often come with tradeoffs—added sugars, sugar alcohols, artificial flavors, or ingredients that don’t align with cleaner-label preferences. Swisse is leaning into the opposite approach. According to the company, Glam Bites are crafted with:
Zero sugar
No sugar alcohols
No artificial flavors, colors, or sweeteners
Gluten-free
Free from major allergens (milk, eggs, fish, crustacean shellfish, peanuts, wheat, soybeans, sesame)
That “clean but still tasty” promise is a big part of the launch—especially as more shoppers look for supplements that fit into wellness routines without feeling like a compromise.
A beauty routine that starts from the inside
Swisse is framing Glam Bites as a simple daily add-on that supports skin, hair, and nails through targeted micronutrients. Leading dietitian Dana A. White highlighted the brand’s approach in the announcement, noting that Glam Bites deliver “powerful, science-driven beauty benefits” through a precisely balanced blend of nutrients—while keeping the formula free from artificial colors, flavors, and sweeteners.
The Glam Bites lineup (available now)
Swisse launched Glam Bites in three formulas, each with its own ingredient blend and naturally flavored profile.
1) Hair Skin Nails Glam Bites
Price/Count: $19.99 (60 count)
Key ingredients: Biotin, Zinc, Bamboo Extract
What it supports: Stronger hair and nails, plus skin firmness and elasticity*
Flavor: Blood orange (naturally flavored)
2) Glow Skin Glam Bites
Price/Count: $24.99 (60 count)
Key ingredients: Hyaluronic Acid, Vitamins C & E, Sea Moss, Hydrolyzed Marine Collagen Peptides
What it supports: Collagen production, improved elasticity, and a stronger skin barrier*
Flavor: Blueberry lavender (naturally flavored)
3) Skin Defense Glam Bites
Price/Count: $24.99 (60 count)
Key ingredients: Astaxanthin, L-Glutathione, Green Tea Extract
What it supports: Healthy aging, even skin tone, and antioxidant protection against environmental stressors*
Flavor: Raspberry green tea (naturally flavored)
Why gummies—and why now?
Swisse is launching Glam Bites at a time when gummies are increasingly becoming the preferred supplement format for younger consumers. The company cited research showing:
45% of Gen Z and 31% of millennials favor gummy supplements.
74% of U.S. personal care buyers agree that skin health reflects overall health.
In other words: the market is shifting toward convenience, better taste, and wellness products that connect beauty with whole-body health.
A global wellness brand expanding its portfolio
Swisse was founded in Australia in 1969 and has grown into a global wellness name known for premium supplements made with ingredients backed by scientific research and produced under world-class manufacturing standards. With Glam Bites, the brand is clearly betting on a “cleaner gummy” future—one that fits modern routines and modern label expectations.
*These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any disease.
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How C-reactive protein outpaced ‘bad’ cholesterol as leading heart disease risk marker
C-reactive protein (CRP) is a key inflammation marker that can predict heart attack and stroke risk—often better than LDL cholesterol. Here’s why it matters.
C-reactive protein is created by the liver in response to infections, tissue damage, chronic inflammatory states from conditions like autoimmune diseases, and metabolic disturbances like obesity and diabetes. Essentially, it is a marker of inflammation – meaning immune system activation – in the body. C-reactive protein can be easily measured with blood work at the doctor’s office. A low C-reactive protein level – under 1 milligram per deciliter – signifies minimal inflammation in the body, which is protective against heart disease. An elevated C-reactive protein level of greater than 3 milligrams per deciliter, signifies increased levels of inflammation and thus increased risk for heart disease. About 52% of Americans have an elevated level of C-reactive protein in their blood. Research shows that C-reactive protein is a better predictive marker for heart attacks and strokes than “bad,” or LDL cholesterol, short for low-density lipoprotein, as well as another commonly measured genetically inherited biomarker called lipoprotein(a). One study found that C-reactive protein can predict heart disease just as well as blood pressure can.
Why does inflammation matter in heart disease?
Inflammation plays a crucial role at every stage in the development and buildup of fatty plaque in the arteries, which causes a condition called atherosclerosis that can lead to heart attacks and strokes. From the moment a blood vessel is damaged, be it from high blood sugar or cigarette smoke, immune cells immediately infiltrate the area. Those immune cells subsequently engulf cholesterol particles that are typically floating around in the blood stream to form a fatty plaque that resides in the wall of the vessel. This process continues for decades until eventually, one day, immune mediators rupture the cap that encloses the plaque. This triggers the formation of a blood clot that obstructs blood flow, starves the surrounding tissues of oxygen and ultimately causes a heart attack or stroke. Hence, cholesterol is only part of the story; it is, in fact, the immune system that facilitates each step in the processes that drive heart disease.Fatty plaque buildup in the arteries causes a blockage that starves tissues of oxygen and can lead to a heart attack or stroke.wildpixel/iStock via Getty Images Plus
Does cholesterol still matter for heart disease risk?
Though cholesterol may not be the most important predictor of risk for heart disease, it does remain highly relevant. However, it’s not just the amount of cholesterol – or more specifically the amount of bad, or LDL, cholesterol – that matters. Two people with the same cholesterol level don’t necessarily have the same risk for heart disease. This is because risk is determined more so by the number of particles that the bad cholesterol is packaged into, as opposed to the total mass of bad cholesterol that’s floating around. More particles means higher risk. That is why a blood test known as apolipoprotein B, which measures the number of cholesterol particles, is a better predictor of risk for heart disease than measurements of total amounts of bad cholesterol. Like cholesterol and C-reactive protein, apolipoprotein B is also influenced by lifestyle factors like exercise, weight loss and diet. Nutrients like fiber, nuts and omega-3 fatty acids are associated with a decreased number of cholesterol particles, while increased sugar intake is associated with a larger number of cholesterol particles. Furthermore, lipoprotein(a), a protein that lives in the wall surrounding cholesterol particles, is another marker that can predict heart disease more accurately than cholesterol levels. This is because the presence of lipoprotein(a) makes cholesterol particles sticky, so to speak, and thus more likely to get trapped in an atherosclerotic plaque. However, unlike other risk factors, lipoprotein(a) levels are purely genetic, thus not influenced by lifestyle, and need only be measured once in a lifetime.
What’s the best way to prevent heart disease?
Ultimately, heart disease is the product of many risk factors and their interactions over a lifetime. Therefore, preventing heart disease is way more complicated than simply eating a cholesterol-free diet, as once thought. Knowing your LDL cholesterol level alongside your C-reactive protein, apolipoprotein B and lipoprotein (a) levels paints a comprehensive picture of risk that can hopefully help motivate long-term commitment to the fundamentals of heart disease prevention. These include eating well, exercising consistently, getting adequate sleep, managing stress productively, maintaining healthy weight and, if applicable, quitting smoking.Mary J. Scourboutakos, Adjunct Assistant Professor in Family and Community Medicine, Macon & Joan Brock Virginia Health Sciences at Old Dominion University This article is republished from The Conversation under a Creative Commons license. Read the original article.
How to reduce gift-giving stress with your kids – a child psychologist’s tips for making magic and avoiding tears
Reduce gift-giving stress with kids: A child psychologist shares practical rules for stress-free gift giving with kids—how many gifts to give, what holds attention, and how to avoid holiday tears.
’Tis the season … for gift-buying stress. Photo by Ryan Miller/Invision/AP
How to reduce gift-giving stress with your kids – a child psychologist’s tips for making magic and avoiding tears
Angela J. Narayan, University of Denver As a child, I loved being the center of attention. So it was a problem when my baby brother was born a day before my birthday. For years, I would beg my parents for a birthday gift “one day early.” My laid-back brother remembers thinking, “I don’t care about presents. Just give her mine!” As an associate professor and child psychologist at the University of Denver who studies child development and parenting, I’ve come to learn about these types of challenges associated with gift giving. The holidays, while a magical time, can also be stressful. Society places an expectation on parents to buy gifts, regardless of their financial circumstances, and children themselves often feel a variety of complex emotions. How children react to getting presents is partially linked to temperament, which is the variety of ways that children experience, perceive and interact with the world. Temperament is the precursor to personality – some people are introverts, while others are extroverts. Temperament is partially heritable. That means an introverted parent who feels social pressure to buy many gifts for their shy and easily overwhelmed child may be inadvertently causing stress. Faced with this holiday conundrum, I’m often asked questions like “Is there a magic number of gifts to give my kids?” or “What gifts will hold my child’s attention the longest?” While there isn’t an easy answer to either question, these tips and tricks can help parents be more thoughtful and intentional about gift giving, especially for children who are young.
The age rule
Young children cannot focus on a lot of things at once. A good rule of thumb is that a 1-year-old can focus only on one thing at a time. A 2-year-old can maybe focus on two things at most, and a 3-year-old maybe three things, and so on. Stop at five. Very few children actually need more than five gifts, so feel free to go lower.
The attention rule
I have often searched for the magical gift that will keep my children occupied for hours, and so far I haven’t found it. What I have found is that my children – ages 5 and 7 – get excited about the things that I get excited about. So I try to buy things that I think are fun. Ask yourself what you would like to play with if you got to be a child again. I bet your children would be eager to join you in those things.
The games rule
Card and board games are great gifts, often inexpensive, fun for many ages – excepting babies, of course – and capable of holding attention for a long time. Plus, they usually don’t take up much storage space. I love giving my kids games that are not only fun but also teach them helpful skills. Collaborative games for preschoolers and early school-age children like the Fairy Game and Outfoxed teach problem-solving, teamwork and early reasoning skills. Games for elementary-age children, such as Sorry and Battleship, teach kids how to manage difficult situations, like not always being in the lead, being a good sport even if you’re behind, and losing gracefully. Timeless card games like Uno and Memory, and newer ones like Sleeping Queens and Exploding Kittens, are great for using working memory, thinking flexibly, persisting and strategizing. Most importantly, playing games together supports positive family time, which is an excellent antidote to stress, bad moods or boredom.
The pressure rule
Imagine the holiday experience through the eyes of each of your children. Some children relish receiving gifts, like I did. Others, however, may feel self-conscious, overwhelmed by the sensory overload – all the textures, commotion and bright colors, not to mention people staring at them. The elements of surprise combined with the unspoken social pressure to be gracious and well regulated are challenging for any young child. We expect small children to contain their excitement, delay gratification and react positively to the surprise. And then come up with a polite response. These are all complex requests, rarely directly or explicitly taught. It’s no wonder that many children show negative emotions, have tantrums, or even just say, “I’m tired!” during holiday celebrations. That’s why beyond the precise nature of “the perfect gift,” we shouldn’t lose sight of what we should be doing. And that is investing in togetherness and helping kids learn skills like being patient and taking turns, strengthening memory capacities, planning ahead, not giving up, and that being a team player will pay off later. These skills pave the way for longer sustained attention, focus and concentration, as well as confidence. My 7-year-old is becoming a skillful chess player because we have taught him the rules and strategy and helped him practice. Maybe this is the real magical gift – not the purchase itself, but the decision to invest in time with your child early. Angela J. Narayan, Associate Professor, Clinical Child Psychology Ph.D. program, University of Denver This article is republished from The Conversation under a Creative Commons license. Read the original article.
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Mary J. Scourboutakos, Adjunct Assistant Professor in Family and Community Medicine, Macon & Joan Brock Virginia Health Sciences at Old Dominion University This article is republished from The Conversation under a Creative Commons license. Read the original article.
