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FDA Approval of Nonsteroidal Treatment for Duchenne Muscular Dystrophy

Breaking news! FDA approves Duvyzat for Duchenne Muscular Dystrophy, a nonsteroidal treatment providing hope for patients and families. #DMD #FDAApproval

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Breaking news in the medical world! The U.S. Food and Drug Administration has just approved Duvyzat (givinostat), an oral medication for the treatment of Duchenne Muscular Dystrophy (DMD) in patients six years of age and older. Duvyzat is making history as the first nonsteroidal drug approved to treat patients with all genetic variants of DMD. This is a significant milestone in the treatment of this devastating disease.

DMD, being the most common childhood form of muscular dystrophy, primarily affects males. It is a neurological disorder that leads to progressive muscle weakness due to a lack of dystrophin, a muscle protein. Over time, the muscles deteriorate, causing difficulties with walking, muscle strength, and eventually leading to breathing problems and early death. However, with advancements in treatment, the life expectancy for individuals with DMD has been steadily increasing, with some patients surviving beyond 30 years.

Duvyzat is a histone deacetylase (HDAC) inhibitor that targets pathogenic processes to reduce inflammation and loss of muscle in patients with DMD. Its efficacy for the treatment of DMD was evaluated in an 18-month phase 3 study involving a randomized, double-blind, placebo-controlled trial. The primary endpoint of the study was the change in muscle function, measured by the time it took patients to climb four stairs. Patients treated with Duvyzat showed a statistically significant reduction in the decline of muscle function compared to placebo.

Another measure of efficacy was the change in physical function assessed by the North Star Ambulatory Assessment (NSAA), a scale commonly used to rate motor function in boys with DMD who can still walk. Patients treated with Duvyzat experienced less worsening in their NSAA scores after 18 months, compared to those on placebo.

Like any medication, Duvyzat does come with some potential side effects. The most common ones reported were diarrhea, abdominal pain, a decrease in platelets, nausea/vomiting, an increase in triglycerides, and fever. It’s important for healthcare providers to evaluate a patient’s platelet counts and triglyceride levels before prescribing Duvyzat. Patients with low platelet counts should not take the drug. Monitoring of platelet counts and triglycerides throughout treatment will help determine if any dosage adjustments are needed.

Healthcare professionals should also be aware that Duvyzat may cause QTc prolongation, which can increase the risk of irregular heartbeats. It’s crucial for patients taking other medications known to cause QTc prolongation or with certain types of heart disease to avoid taking Duvyzat.

The recommended dosage of Duvyzat is determined by the patient’s body weight, and it should be taken orally twice daily with food.

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The approval of Duvyzat was granted to Italfarmaco S.p.A., and it received priority review, fast-track designation, as well as orphan drug and rare pediatric disease designations from the FDA. This demonstrates the agency’s commitment to advancing the development of new therapies for DMD and its recognition of the urgent need for effective treatments.

This milestone approval represents hope and progress for individuals and families affected by DMD. It provides another treatment option to help reduce the burden of this progressive and debilitating disease, regardless of the specific genetic mutation. With continued advancements in medical research and the dedication of organizations like the FDA, we are moving closer to a future where individuals with DMD can lead healthier lives.

As always, it’s important to consult with healthcare professionals for more information and guidance regarding Duvyzat and its suitability for individual cases. Let’s celebrate this achievement in medical science and look forward to more groundbreaking developments in the treatment of Duchenne Muscular Dystrophy.

Source: FDA

Related Information

  • Duchenne muscular dystrophy – About the Disease – Genetic and Rare Diseases Information Center
  • The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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FDA CDC News

Alert: Kroger Issues Food Recalls Affecting Multiple States

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Senior woman with tablet computer in the store.

As of early February 2025, Kroger has announced a series of food recalls affecting customers across at least 15 states, as well as several subsidiary stores nationwide. The recalls, initiated due to safety concerns, include a variety of products that consumers should be aware of.

Twelve Hummus Tubs from King Harvest

Kroger subsidiary stores Fred Meyer and QFC, located in Alaska, Idaho, Oregon, and Washington, have recalled the following King Harvest hummus tubs, each weighing 10 oz:

  • King Harvest Lemon Hummus
  • King Harvest Classic Hummus
  • King Harvest Roasted Garlic Hummus
  • King Harvest Toasted Onion Hummus
  • King Harvest Chipotle Hummus
  • King Harvest Spinach Hummus
  • King Harvest Black Olive Hummus
  • King Harvest Sesame Hummus
  • King Harvest Jalapeño Hummus
  • King Harvest Balsamic Hummus
  • King Harvest Sun Dried Tomato Hummus
  • King Harvest Roasted Pepper Hummus

These products were recalled on February 5, 2025, due to a defect in their plastic tubs that may lead to the presence of plastic foreign objects within the containers. Kroger has advised customers, “Customers who purchased any of the item(s) below should not eat the product.” It remains unclear whether this recall is connected to a previous incident from September 2024 involving similar concerns.

DJs Boudain Products in Texas and Louisiana

Kroger stores in Texas and Louisiana have also issued a recall for the following DJs Boudain products:

  • DJs Boudain Hot Jalapeño Boudain, 12 oz
  • DJs Boudain Boudain Sausage, 24 oz
  • DJs Boudain Boudain Sausage, 16 oz

These items were recalled on February 1, 2025, due to potential contamination with pieces of a pen. This recall is part of a broader action directed by the U.S. Department of Agriculture (USDA), which called for around 17,720 pounds of boudain sausage link products to be removed from stores across Louisiana, Mississippi, and Texas.

Gerber Products for Teething Children

In addition, two Gerber products intended for teething children were recalled from Kroger stores across multiple states, including Ohio, Virginia, Michigan, Indiana, Illinois, Missouri, Kentucky, Tennessee, Alabama, North Carolina, West Virginia, Texas, and Louisiana. The affected products are:

  • Gerber Soothe N Chew Teething Sticks Banana, 3.2 oz
  • Gerber Soothe N Chew Teething Sticks Strawberry Apple, 3.2 oz

These products were removed from shelves due to potential choking hazards. Kroger has assured customers that those who purchased these items can return them for a full refund. This recall is part of a nationwide action announced by the Food and Drug Administration (FDA). Gerber has expressed regret over the situation, stating, “The recall was initiated after receiving consumer complaints of choking incidents. To date, one emergency room visit has been reported to the firm…We sincerely apologize for any concern or inconvenience this action represents to parents, caregivers, and retail customers.”

Conclusion

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Customers who have purchased any of the recalled products are urged to refrain from consuming them and to return the items for a refund. It is always advisable to stay informed about food recalls to ensure the safety of you and your family. For more updates on recalls and food safety, keep an eye on announcements from Kroger and the relevant health authorities. Stay safe!

STM Daily News is a vibrant news blog dedicated to sharing the brighter side of human experiences. Emphasizing positive, uplifting stories, the site focuses on delivering inspiring, informative, and well-researched content. With a commitment to accurate, fair, and responsible journalism, STM Daily News aims to foster a community of readers passionate about positive change and engaged in meaningful conversations. Join the movement and explore stories that celebrate the positive impacts shaping our world.

Read the article in Newsweek: https://www.newsweek.com/kroger-food-recalls-issued-15-states-full-list-products-impacted-2027160

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A Bold Move Towards a Healthier Future: FDA’s Proposed Nicotine Regulation

On January 15, 2025, the FDA proposed regulating nicotine levels in cigarettes to minimize addiction, aiming to prevent millions from smoking. This significant public health initiative promotes fewer smoking-related diseases and economic benefits.

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On January 15, 2025, the U.S. Food and Drug Administration (FDA) made headlines with a groundbreaking proposal that could revolutionize the landscape of tobacco products. The agency announced a plan to limit the nicotine content in cigarettes and certain combusted tobacco products to levels that will make them minimally or nonaddictive. This significant step is geared towards preventing future generations from falling victim to the perils of tobacco addiction and smoking-related diseases.

A Bold Move Towards a Healthier Future: FDA’s Proposed Nicotine Regulation

A Step Long in the Making

The journey to this proposal began in 2018 when the FDA first expressed intentions to regulate nicotine levels in tobacco products. Now, as we stand on the brink of potentially transformative change, it’s clear that the FDA’s vision is not only ambitious but also rooted in a wealth of scientific evidence. The proposed nicotine cap, set at a mere 0.7 milligrams per gram of tobacco, is poised to dismantle the addictive potential of cigarettes, thus reducing the likelihood of new smokers picking up the habit.

Saving Lives and Reducing Costs

The impact of this regulation could be enormous. According to the FDA’s research, by the year 2100, this new nicotine standard has the potential to prevent around 48 million young people from starting to smoke. Additionally, it could encourage over 12.9 million current smokers to quit within the first year of the regulation’s enactment—numbers that elevate to an astonishing 19.5 million after five years. Ultimately, the FDA estimates that over the coming decades, we could see 1.8 million lives saved, climbing even higher to 4.3 million by the end of the century.

The financial implications are just as compelling. With an estimated annual benefit of over $1.1 trillion—not to mention the reduction in healthcare costs, lost productivity, and the avoidance of tobacco-related diseases—the proposal is not only a public health victory but also an economic one.

A Public Health Perspective

Cigarettes remain the deadliest consumer product in history, accounting for nearly half a million preventable deaths each year in the U.S. alone. The FDA Commissioner Robert M. Califf, M.D., expressed a clear commitment to making significant progress in combating this public health crisis. “Today’s proposal envisions a future where it would be less likely for young people to use cigarettes and more individuals who currently smoke could quit or switch to less harmful products,” he stated.

The focus on addiction prevention and smoking cessation aligns with a broader goal: to create a healthier society where smoking-related diseases are no longer a pervasive threat. The proposed rule does not impose a ban on tobacco products but instead aims to create a safer environment by altering the products themselves. This is a crucial distinction as it allows for a path that encourages adult smokers to transition to less harmful alternatives without criminalizing their existing choices.

Why Public Engagement Matters

With the proposal open for public comment from January 16 to September 15, 2025, the FDA is keen on gathering input from diverse stakeholders, ensuring that a myriad of perspectives is considered. This effort to foster public dialogue is essential as it demonstrates a collaborative approach to policymaking, inviting the voices of health advocates, smokers wishing to quit, and the general public into the conversation.

The FDA is also reaching out to its Tobacco Products Scientific Advisory Committee to explore further implications of this proposal, underlining the importance of scientific scrutiny in shaping effective tobacco regulations.

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Looking Ahead

As we await the final decision on this transformative proposal, the message is clear: reducing nicotine levels in combusted tobacco products could redefine smoking norms in America. The FDA’s intent to prioritize public health and encourage cessation underscores a commitment to safeguarding future generations.

While no tobacco product is completely safe and the best choice for individual health is to avoid all forms of tobacco, the proposed regulations represent a critical stride towards mitigating the risks associated with smoking. With collective efforts and robust community engagement, a healthier future is not only possible, but within reach.

Join the Conversation

Are you interested in contributing to this historic movement? The FDA encourages public input, and your voice matters! Take part in this important conversation in shaping the future of tobacco regulation. Together, we can help create a society where smoking-related deaths are significantly reduced, and a healthier lifestyle becomes the norm.

Stay engaged, stay informed, and let’s pave the way for a smoke-free future!

Related links:

https://www.fda.gov/advisory-committees/committees-and-meeting-materials/tobacco-products-scientific-advisory-committee

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Additional Resources:

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.

SOURCE U.S. Food and Drug Administration

Our Lifestyle section on STM Daily News is a hub of inspiration and practical information, offering a range of articles that touch on various aspects of daily life. From tips on family finances to guides for maintaining health and wellness, we strive to empower our readers with knowledge and resources to enhance their lifestyles. Whether you’re seeking outdoor activity ideas, fashion trends, or travel recommendations, our lifestyle section has got you covered. Visit us today at https://stmdailynews.com/category/lifestyle/ and embark on a journey of discovery and self-improvement.


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FDA Issues Class I Recall for Costco’s Kirkland Signature Smoked Salmon

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Piece of the raw salmon on the plate

In a significant health alert, the U.S. Food and Drug Administration (FDA) has upgraded the recall of Costco’s Kirkland Signature Smoked Salmon to a Class I designation, indicating a serious health risk. This recall follows the discovery of Listeria monocytogenes during routine laboratory testing.

Originally announced in late October, the recall involved 111 cases of smoked salmon packaged in twin 12-ounce units, with a UPC number of 0 96619 25697 6 and a lot number of 8512801270. The affected products have a best-by date of November 13, 2024, and were distributed between October 9 and October 13, 2024, specifically to Costco locations in Florida.

Listeria monocytogenes is known to cause listeriosis, a severe infection that can result in serious health complications or even death, especially among vulnerable populations such as pregnant individuals, the elderly, and those with weakened immune systems. Although no illnesses have been reported in connection with this product, consumers are advised to check their freezers for these recalled items.

FDA Issues Class I Recall for Costco’s Kirkland Signature Smoked Salmon

Costco is urging customers who purchased this product to return it for a full refund.

For your safety, the FDA reminds consumers that Listeria can be found in a variety of foods, particularly raw or smoked seafood, unpasteurized dairy products, and deli meats. If you suspect you may have consumed contaminated food, please consult with a healthcare professional.

Stay safe and informed by regularly checking for updates on food recalls from reliable sources.

Related links:

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The FDA Issued a Class I Recall on Costco’s Kirkland Signature Smoked Salmon https://www.foodandwine.com/costco-kirkland-signature-smoked-salmon-class-i-recall-listeria-monocytogenes-8780336

https://www.fda.gov/food/foodborne-pathogens/listeria-listeriosis

STM Daily News is a vibrant news blog dedicated to sharing the brighter side of human experiences. Emphasizing positive, uplifting stories, the site focuses on delivering inspiring, informative, and well-researched content. With a commitment to accurate, fair, and responsible journalism, STM Daily News aims to foster a community of readers passionate about positive change and engaged in meaningful conversations. Join the movement and explore stories that celebrate the positive impacts shaping our world.

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Groundbreaking for a Sustainable Future: LA Metro’s Southeast Gateway Line Light Rail Project


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