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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
Last Updated on March 21, 2024 by Daily News Staff
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.
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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Is Hormone Replacement Therapy Safe? What the FDA’s New Decision Means for Menopause Treatment
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Nationwide Shrimp Recall Expands to Arizona: What You Need to Know
Nationwide Shrimp Recall: AquaStar has recalled Kroger, Kroger Mercado, and AquaStar frozen shrimp in Arizona and other states due to possible cesium-137 contamination. Check UPCs, lot codes, and best-by dates to see if your shrimp is affected.
Last Updated on September 26, 2025 by Daily News Staff
Steamed shrimp on plate
Nationwide Shrimp Recall Expands to Arizona: What You Need to Know
A major frozen shrimp recall is currently underway across the United States — and Arizona shoppers are directly affected. AquaStar (USA) Corp has announced a recall of multiple frozen shrimp products, both raw and cooked, due to potential contamination with cesium-137 (Cs-137), a radioactive substance.
Products Included in the Recall
The recall covers several popular brands and package types, including:
Kroger Raw Colossal EZ Peel Shrimp (2 https://stmdailynews.com/cash-trapping-how-to-protect-yourself-from-this-sneaky-atm-scam/ bag)
Kroger Mercado Cooked Medium Peeled Tail-Off Shrimp (2 lb bag)
AquaStar Raw Peeled Tail-On Shrimp Skewers (1.25 lb bag)
AquaStar Cocktail Shrimp trays (sold at Walmart and other retailers)
In total, more than 85,000 packages of shrimp have been pulled from stores nationwide. These products were distributed to several states, including Arizona, between June and September 2025.
Why the Recall?
Routine testing detected the presence of cesium-137, a radioactive contaminant. While no illnesses or adverse reactions have been reported, long-term exposure to Cs-137 may increase the risk of certain cancers. Out of caution, the FDA and AquaStar urge consumers not to eat these shrimp.
🔍 How to Identify the Recalled Shrimp
Shoppers should look at UPC codes, lot codes, and best-by dates printed on the packaging. Here are the specific products under recall:
Product | UPC | Lot Code(s) | Best-By Date(s) |
|---|---|---|---|
Kroger Raw Colossal EZ Peel Shrimp (2 lb) | 20011110643906 | 10662 5085 10 · 10662 5097 11 · 10662 5106 11 · 10662 5107 10 · 10662 5111 11 · 10662 5112 10 · 10662 5113 10/11 · 10662 5114 10/11 | March 26 2027 · April 7 2027 · April 16–24 2027 |
Kroger Mercado Cooked Medium Peeled Tail-Off Shrimp (2 lb) | 011110626196 | 10662 5112 11 · 10662 5113 10 | October 22–23 2027 |
AquaStar Raw Peeled Tail-On Shrimp Skewers (1.25 lb) | 731149390010 | 10662 5127 10 · 10662 5128 11 · 10662 5133 11 · 10662 5135 10 | November 7–15 2027 |
AquaStar Cocktail Shrimp Trays (Walmart) | 19434612191 | 10662 5106 · 10662 5107 · 10662 5124 · 10662 5125 | Dates vary by lot |
What Should Consumers Do?
Check your freezer for the affected shrimp products.
Do not eat them. If you have the recalled shrimp, throw it away or return it to the store where it was purchased.
Stay updated. The FDA continues to monitor the situation and will provide further updates as needed.
No Reported Illnesses So Far
Although the recall sounds alarming, health officials stress that no illnesses have been linked to these shrimp products at this time. The move is a precaution to protect consumers.
👉 Bottom line for Arizona shoppers: If you’ve bought frozen shrimp from Kroger, Kroger Mercado, or AquaStar between June and September 2025, check the packaging details immediately. When in doubt, don’t eat it.
🔗 Resources for More Information
FDA Recall Notice – AquaStar USA Corp Recalls Kroger & AquaStar Frozen Shrimp
FDA Advisory – Do Not Eat, Sell, or Serve Certain Imported Frozen Shrimp
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Deadly ‘Kissing Bug’ Disease in Arizona: What You Need to Know
Learn about Chagas disease in Arizona, where kissing bugs are found, symptoms to watch for, treatment options, and prevention tips to protect your home and family.
Last Updated on September 8, 2025 by Daily News Staff
Chagas disease, often called the “kissing bug disease,” has been making headlines as it spreads in the United States. Arizona is one of the states where kissing bugs (Triatoma species) are common, particularly in the southern region. While confirmed human infections in Arizona have not been directly traced to bug bites, the insects are present, and many carry the parasite responsible for Chagas disease—making awareness and prevention critical.
Where Kissing Bugs Are Found in Arizona
Southern Arizona is a known hotspot for kissing bugs, with heavy activity in areas like:
Tucson and surrounding Pima County Cochise County Desert areas with packrat nests or outdoor animal enclosures
These insects are most active during late spring through early summer—from mid-May to mid-July—when they fly in search of food and shelter. Studies show that nearly half of the bugs collected in Arizona carry Trypanosoma cruzi, the parasite that causes Chagas disease.
How Kissing Bugs Spread Chagas Disease
Kissing bugs feed on the blood of humans and animals, often at night. Unlike mosquitoes, they don’t transmit the parasite through their bite itself. Instead, infection happens when:
The bug defecates near the bite wound and the parasite enters the skin through scratching. Contaminated bug droppings come into contact with the eyes, mouth, or open cuts.
Symptoms of Chagas Disease
Many people may not notice symptoms right away, but there are two phases of illness:
Acute Phase (weeks to months after infection)
Swelling or redness at the bite site Fever, fatigue, body aches Swollen eyelid (called Romana’s sign, a key indicator) Rash or loss of appetite
Chronic Phase (years later if untreated)
Heart problems (arrhythmias, enlarged heart, heart failure) Digestive issues (difficulty swallowing, severe constipation) Potentially life-threatening complications
If you suspect exposure, consult a doctor immediately. A blood test can confirm infection, and treatment is most effective when started early.
Treatment Options
Antiparasitic medications such as Benznidazole and Nifurtimox are available in the U.S. through the CDC. Treatment is most effective during the acute phase but may still help prevent complications in chronic cases. Doctors may also recommend heart or gastrointestinal monitoring for patients with chronic Chagas disease.
How to Prevent Kissing Bug Infestations
While human transmission in Arizona is rare, preventing bug exposure is the best protection.
Around Your Home
Seal cracks and gaps around doors, windows, roofs, and walls. Install and maintain window and door screens. Reduce outdoor lighting at night—bugs are drawn to light. Remove packrat nests, woodpiles, and debris near the home that can harbor kissing bugs. Keep pet sleeping areas clean and ideally indoors.
If You Find a Bug Indoors
Do not squash it with bare hands. Use a jar, plastic bag, or tissue to capture it safely. Freeze the bug or place it in rubbing alcohol for identification. Report findings to local health authorities or university research programs.
Key Takeaway
Southern Arizona—especially Tucson and surrounding counties—has a well-documented population of kissing bugs, many carrying the parasite that causes Chagas disease. While locally acquired human infections are rare, awareness and prevention are essential.
By sealing up your home, reducing nighttime exposure, and learning the signs of Chagas disease, you can greatly reduce your risk. If you notice unusual symptoms after possible exposure, don’t wait—get tested and treated early.
Related Links
CDC: Chagas Disease Information
University of Arizona Health Sciences:
Summertime Kissing Bug Season in Arizona
Texas A&M University: Kissing Bug Resource
National Library of Medicine: Chagas Disease in the United States
World Health Organization: Chagas Disease (American trypanosomiasis)
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