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FDA Approves Omisirge, a Cell Therapy for Blood Cancer Patients Undergoing Stem Cell Transplantation

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Last Updated on April 17, 2023 by Daily News Staff

The FDA has recently approved a cell therapy called Omisirge (omidubicel-onlv) for patients with blood cancers who are undergoing stem cell transplantation. This allogeneic cord blood-based cell therapy can help speed up the recovery of neutrophils in the body, a type of white blood cell, and reduce the risk of infection. Omisirge is intended for use in adults and pediatric patients 12 years and older with blood cancers who are scheduled for umbilical cord blood transplantation following a myeloablative conditioning regimen.

Blood cancers can be fatal, and a stem cell transplant is a common treatment option. The process involves placing healthy stem cells into the body to help restore the normal production and function of blood cells. One source of healthy stem cells is umbilical cord blood. Before receiving this transplant, the patient will undergo a course of treatments to remove their own stem cells and prepare the body for the new stem cells. However, this process can weaken the patient’s immune system, making them vulnerable to infections.

Omisirge is composed of human allogeneic stem cells from umbilical cord blood that are processed and cultured with nicotinamide. It comes from a different individual rather than using the patient’s own cells. A randomized, multicenter study compared transplantation of Omisirge to transplantation of umbilical cord blood in subjects between the ages of 12 and 65 years. All subjects in the study had confirmed blood cancers. The efficacy of Omisirge was based on the amount of time needed for recovery of the subject’s neutrophils and the incidence of infections following transplantation.

The study showed that 87% of subjects who received Omisirge achieved neutrophil recovery with a median of 12 days following treatment with the product, compared to 83% of subjects who received umbilical cord blood transplantation and who achieved neutrophil recovery with a median of 22 days. Bacterial or fungal infections by 100 days following transplantation were seen in 39% of subjects receiving Omisirge versus 60% of subjects in the control group who received umbilical cord blood.

However, treatment with Omisirge has the potential to cause severe side effects, which must be considered in assessing the risks and benefits of using this product. Patients who receive Omisirge should be monitored for signs and symptoms of infusion reactions, graft versus host disease, engraftment syndrome, graft failure, transmission of serious infections or rare genetic diseases from the donor cells, as well as lifelong for secondary malignancies.

Omisirge is a breakthrough therapy in cell therapy treatment for patients with blood cancers, and its approval reflects the FDA’s commitment to supporting the development of innovative therapies for life-threatening cancers. Although it carries some risks, Omisirge is expected to help many patients with blood cancers who are undergoing stem cell transplantation.

https://www.fda.gov/news-events/press-announcements/fda-approves-cell-therapy-patients-blood-cancers-reduce-risk-infection-following-stem-cell?utm_medium=email&utm_source=govdelivery

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Women's Health

Is Hormone Replacement Therapy Safe? What the FDA’s New Decision Means for Menopause Treatment

For more than 20 years, hormone replacement therapy for menopause has carried a warning label from the Food and Drug Administration describing the medication’s risk of serious harms – namely, cancer, cardiovascular disease and possibly dementia.

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Last Updated on November 19, 2025 by Daily News Staff

file 20251117 56 24vjj5.jpg?ixlib=rb 4.1
Reanalyses of earlier research have shown that hormone therapy is safe and effective for many women going through menopause. monkeybusinessimages/iStock via Getty Images Plus

I treat menopause and its symptoms, and hormone replacement therapy can help – here’s the science behind the FDA’s decision to remove warnings

Genevieve Hofmann, University of Colorado Anschutz Medical Campus For more than 20 years, hormone therapy for menopause has carried a warning label from the Food and Drug Administration describing the medication’s risk of serious harms – namely, cancer, cardiovascular disease and possibly dementia. On Nov. 10, 2025, the FDA announced that drugmakers should remove these “black box” safety warnings. The Conversation U.S. asked Genevieve Hofmann, a women’s health nurse practitioner at the University of Colorado Anschutz Medical Campus, to explain how the decision will affect health care for people going through menopause or postmenopause.

How did the FDA’s decision come about?

When people think of hormone therapy for menopause, they generally think of systemic estrogen and progestogens – for example, pills or patches that deliver hormones throughout the body. Health care providers prescribed hormone therapy to manage symptoms of menopause such as hot flashes, night sweats and brain fog much more widely in the 1980s and 1990s than they do today. That’s because in the early 2000s, researchers analyzed data from a study called the Women’s Health Initiative and reported that hormone therapy increased the risk of breast cancer, heart disease, blood clots and stroke, as well as cognitive decline after menopause. After this research was first published in 2002, the use of hormone therapy fell by 46% within six months – both because clinicians were reluctant to prescribe it and patients were fearful of taking it. In 2003, the FDA added black box warnings – the most serious warnings, indicating a risk of serious harm or death – to all estrogen-containing hormone products for menopause.
The FDA announced on Nov. 10, 2025, that it will ask drug companies to remove ‘black box’ warnings from hormone therapy for menopause.
But researchers soon pointed out methodological flaws in the analysis. And over the past two decades, careful reanalyses of data from that study, as well as newer studies, have shown that systemic hormone therapy is very safe for most women, though there are nuances surrounding its use. Meanwhile, women’s health experts have been increasingly vocal in the past five years in calling to remove the black box warnings from a form of hormone menopause therapy that’s applied locally, not systemically. Topical localized estrogen is applied directly to the vagina and surrounding areas, usually in the form of a cream or vaginal insert. It’s used to treat the genitourinary syndrome of menopause, which manifests as genital and urinary symptoms. Even though topical estrogen products are extremely safe and were not evaluated in the Women’s Health Initiative study, the FDA warnings were added to them, too. In July 2025, the FDA held an expert panel to discuss what’s currently known about the risks and benefits of hormone therapy for menopause. At the meeting, most experts urged the agency to remove the warning labels on topical vaginal estrogen products. The Nov. 10 announcement was the outcome of that discussion, and it included both systemic and topical hormone therapy.

Why is systemic estrogen no longer considered unsafe?

Researchers are now finding that the balance of risks and benefits of systemic hormone therapy for menopause seems to depend strongly on when someone starts hormones, as well as the type, dose and length of use. For women under 60 or within 10 years of their final period, the therapy is much safer than it is for older women. A 2017 follow-up of Women’s Health Initiative participants showed that overall deaths from any causes actually decreased in this younger cohort of menopausal women taking hormones. For women who are more than 10 years from their final menstrual period, starting hormone therapy may increase their risk of cardiovascular disease. Researchers now refer to this as the timing hypothesis. Newer studies also support this idea. Also, some ways of delivering hormones to the body turned out to be safer than others. Taking estrogen orally, as pills or tablets, carries a higher risk of blood clots. Those risks go away when it’s delivered through the skin using a patch, gel or spray. Many more options for hormone therapy exist today than in the early 2000s. Additionally, it’s well established that hormone therapy improves bone health by preventing bone loss. Some studies suggest that in younger menopausal women, it may actually protect against cardiovascular disease, though this link is not yet proven and needs more study. Unfortunately, many people missed out on the timing window. In my practice, I see patients who went through menopause 10 or 15 years ago and either didn’t get hormone therapy at the time or stopped taking it when the initial Women’s Health Initiative results came out. Now, they are hearing about the benefits, and many want to try it. But their higher cardiovascular risk may overshadow the benefit.

What about topical estrogen?

Genitourinary syndrome of menopause is ubiquitous – it affects every person with ovaries who goes through menopause, and the symptoms tend to worsen with age. They include vaginal dryness, painful sex and urinary issues such as an increase in urgency or frequency, along with incontinence. Urinary tract infections often tend to get more frequent with menopause, particularly in older women. Treating them can require multiple courses of antibiotics. Tissues in the genitourinary area are loaded with estrogen receptors – proteins in cells that bind the hormone. So adding some estrogen back to these areas can help restore the quality and thickness of these tissues, and possibly even promote the growth of healthy bacteria around the vagina and the urinary tract. The treatment can greatly improve quality of life and promote better health and longevity. Despite topical estrogen’s safety and effectiveness, the FDA did not distinguish between it and systemic estrogen when adding the black box warnings in 2003. For this reason, many providers whose patients have symptoms relating to the genitourinary syndrome of menopause have been reluctant to prescribe it. Often, providers simply don’t know that it has a different safety profile than systemic estrogen.

How will removing the black box warnings affect patients?

Overall, I see this as a big win for women and their ability to manage the symptoms of menopause. I think this will make clinicians and patients far less anxious about prescribing and taking this medication. Clinicians like me who specialize in women’s health and menopause – and who have been following the research – have been safely prescribing hormone therapy all along. But many general practitioners who often lacked either menopause-specific training or the time and resources to stay on top of the latest findings have been more reluctant to do so. Safety concerns that led to the black box warnings, especially in regard to local vaginal estrogen, have turned out to be overblown. While clinicians still need to consider who is a good candidate for systemic hormone use, the evidence shows that for most people, it is a safe option. Even more important, patients who were previously convinced that hormone therapy was unsafe may feel more comfortable discussing it with their provider and considering it. And if they do receive a prescription for hormone therapy, I hope that the likelihood of them starting this effective treatment is no longer hindered by reading a scary package insert that was based on outdated evidence. While this medication is not a silver bullet that reverses aging, starting hormones at the right time can safely improve symptoms that diminish people’s quality of life. So if you’re having symptoms that are bothersome, consider asking your provider about menopause hormone therapy to help manage them. Genevieve Hofmann, Assistant Professor of Nursing and Women’s Health, University of Colorado Anschutz Medical Campus This article is republished from The Conversation under a Creative Commons license. Read the original article.

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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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.

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Last Updated on September 26, 2025 by Daily News Staff

Nationwide Shrimp Recall

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)

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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

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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


STM Daily News
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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.

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Last Updated on September 8, 2025 by Daily News Staff

‘Kissing Bug’ Disease in Arizona

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)

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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

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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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