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FDA refuses to review Moderna’s mRNA flu vaccine application

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FDA refuses to review Moderna’s mRNA flu vaccine application

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The U.S. Food and Drug Administration (FDA) refused to consider Moderna’s application for a new flu vaccine using mRNA technology, the company announced Tuesday, a decision that could delay the introduction of a shot designed to offer stronger protection for older adults.

Moderna said it received what’s known as a “refusal-to-file” (RTF) letter from the FDA’s Center for Biologics Evaluation and Research (CBER), citing the lack of an “adequate and well-controlled” study with a comparator arm that “does not reflect the best-available standard of care.”

Stéphane Bancel, chief executive officer of Moderna, said the FDA’s decision did not “identify any safety or efficacy concerns with our product” and “does not further our shared goal of enhancing America’s leadership in developing innovative medicines.”

“It should not be controversial to conduct a comprehensive review of a flu vaccine submission that uses an FDA-approved vaccine as a comparator in a study that was discussed and agreed on with CBER prior to starting,” Bancel said in a statement. “We look forward to engaging with CBER to understand the path forward as quickly as possible so that America’s seniors, and those with underlying conditions, continue to have access to American-made innovations.”

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The FDA refused to review Moderna’s application for a new mRNA-based flu vaccine, citing concerns about the design of its late-stage clinical trial. (iStock)

The rare decision from the FDA comes amid increased scrutiny over vaccine approvals under Health Secretary Robert F. Kennedy Jr., who has criticized mRNA vaccines and rolled back certain COVID-19 shot recommendations over the past year.

Kennedy previously removed members of the federal government’s vaccine advisory panel and appointed new members, and moved to cancel $500 million in mRNA vaccine contracts.

The FDA authorized COVID-19 vaccines for the fall for high-risk groups only. Last May, Kennedy announced the vaccines would be removed from the CDC’s routine immunization schedule for healthy children and pregnant women.

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The FDA’s refusal to review Moderna’s mRNA flu vaccine comes amid broader vaccine policy shifts under Health Secretary Robert F. Kennedy Jr. (Jason Mendez/Getty Images)

According to Moderna, the refusal-to-file decision was based on the company’s choice of comparator in its Phase 3 trial — a licensed standard-dose seasonal flu vaccine — which the FDA said did not reflect the “best-available standard of care.”

Moderna said the decision contradicts prior written communications from the FDA, including 2024 guidance stating a standard-dose comparator would be acceptable, though a higher-dose vaccine was recommended for participants over 65.

Moderna said the FDA “did not raise any objections or clinical hold comments about the adequacy of the Phase 3 trial after the submission of the protocol in April 2024 or at any time before the initiation of the study in September 2024.”

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Moderna said it received a “refusal-to-file” letter from the FDA for its new mRNA flu vaccine, a move that could delay the shot’s rollout. (iStock)

In August 2025, following completion of the Phase 3 efficacy trial, Moderna said it held a pre-submission meeting with CBER, which requested that supportive analyses on the comparator be included in the submission and indicated the data would be a “significant issue during review of your BLA.”

Moderna said it provided the additional analyses requested by CBER in its submission, noting that “at no time in the pre-submission written feedback or meeting did CBER indicate that it would refuse to review the file.”

The company requested a Type A meeting with CBER to understand the basis for the RTF letter, adding that regulatory reviews are continuing in the European Union, Canada and Australia.

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Fox News has reached out to the Department of Health and Human Services for comment.

Fox News Digital’s Alex Miller and The Associated Press contributed to this report.

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One daily habit may help you fight stress and think more clearly, study suggests

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One daily habit may help you fight stress and think more clearly, study suggests

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The practice of combining cold exposure and breathwork — known as the Wim Hof Method — has gained popularity as a wellness practice, with some research suggesting benefits for stress, energy and mental clarity, though evidence for treating chronic disease remains limited.

And now, a recent study published in the journal Nature appears to support the technique’s potential health benefits.

The research included more than 400 healthy adults averaging 37 years of age, who practiced either the Wim Hof Method (WHM) or mindfulness meditation daily for about one month.

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The WHM practitioners were split into in-person and at-home groups, where one did ice baths and the other took cold showers.

The participants reported their energy, mental clarity, and stress and anxiety levels. The researchers also measured heart rate, breathing and sleep.

Wim Hof, creator of the Wim Hof Method that combines cold exposure and breathwork, is pictured among icebergs on Iceland’s Diamond Beach. (Wim Hof Method)

Participants in the breathwork and cold group had greater improvements in energy, mental clarity and ability to handle stress, benefits that were most noticeable right after their daily practice.

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The study also found that meditation reduced stress early on, but the WHM showed gradual improvements in stress levels over a longer time period. Differences in sleep, cognition and heart health measures were more subtle.

The short 29-day study period could pose a limitation in measuring long-term impacts, the researchers acknowledged. 

Wim Hof is pictured meditating in the snow in Switzerland. “I felt that this was going to make a huge difference in people,” he said of his method. (Wim Hof Method)

The participants also knew which group they were placed in, which could have influenced the self-reported results.

“I felt that this was going to make a huge difference in people,” Wim Hof told Fox News Digital. “I had a lot of anecdotal evidence, but that doesn’t make it scientific.”

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What is the Wim Hof Method?

The Wim Hof Method is comprised of three pillars: cold, breathing and mindset.

“It is a combination of the three … and when they come together, they reinforce each other and become stronger,” he said. “Use the cold well, and you bring the immune system, the energy system and your cardiovascular system to an optimum [state].”

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Breathing has been shown to lower inflammation, which is the main driver of disease, according to Wim Hof. Research has also shown that a change in mindset can re-circuit the brain to handle stress more efficiently.

Lowering stress levels is crucial to improving health, he noted, as high cortisol (the body’s stress hormone) and inflammation are drivers of chronic disease.

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Sunday Swim, a group practicing the Wim Hof Method, does a cold plunge on a Long Island beach. (Sunday Swim)

Lead study author Dr. Jemma King, of the University of Queensland School of Psychology in Australia, said she entered the world’s largest Wim Hof study with a “healthy dose of scientific skepticism.”

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“People are really anxious, people are really burnt out, and the world is very destabilized at the moment,” she told Fox News Digital. “People are increasingly dependent on healthcare systems, and profits keep growing and people keep getting sicker.”

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“We’re glued to screens; we’re reaching for pills every time life feels hard. And so we really wanted to [find out] — is there a better way?”

Sunday Swim founder Brendan Cooke assists participants with breathwork on a Long Island beach. (Sunday Swim)

Although meditation is an important tool for some, an alternative method that involves more activity may be a better option for those with “busy brains,” according to the researcher.

“You’re not sitting there just accepting energy,” she said. “You can actually face it head on, and you can overcome your aversion to the cold, which is very invigorating.”

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“If you choose to do small doses of the right kind of stress, it doesn’t break you down. It actually makes you stronger,” King added.

Scientifically, breathwork can help flush the brain of toxins, clearing mental fog while increasing levels of the beneficial chemicals adrenaline and dopamine, she noted.

Cold exposure may not be safe for everyone, especially those with certain cardiovascular conditions. (iStock)

“We also found something really shocking and unexpected: The people doing the Wim Hof Method became more willing to speak up at work,” King shared. “They were more likely to raise hard issues or have a voice or take interpersonal risks.”

“If you train yourself to step into the cold water every morning, you kind of override that voice that says, ‘Don’t do that,’” she added. “This bravery, this toughness that you train every morning, starts to show up everywhere else in your life.”

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Starting safely

For beginners, Hof recommends simply stepping into a cold shower at home, which activates the cardiovascular system and boosts energy.

“Take the cold shower, go into that breathing, and suddenly you’ll feel an innate power awakening,” he said. “That is the nervous system, and you have control over that.”

Cold exposure may not be safe for everyone, especially those with certain cardiovascular conditions, such as abnormal heart rhythms, heart disease or Raynaud’s syndrome, according to Harvard Health.

Those with underlying conditions should get a physician’s approval before embarking on a cold plunge or another mode of cold exposure therapy, experts advise.

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“[For those who] have conditions, I say start with breathing alone,” Hof recommended. “Breathing trains the nervous system like weightlifting trains the muscles.”

“Know that you are built to have willful control over your health, happiness and strength,” he added.

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Mom with no symptoms had stage 4 colorectal cancer — and a rare surgery saved her life

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Mom with no symptoms had stage 4 colorectal cancer — and a rare surgery saved her life

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A Los Angeles mother of three says she’s lucky to be alive after an uncommon procedure left her cancer-free.

Amy Piccioli, a busy CPA, was just 39 when she visited the ER last year for what she thought was dehydration due to a stomach bug.

Instead, a CT scan revealed a mass in her colon and multiple lesions in her liver, which led to a colorectal cancer diagnosis — despite having “zero signs.”

WOMAN’S ALARMING CANCER SYMPTOMS BLAMED ON PREGNANCY FOR YEARS BEFORE STAGE 3 DIAGNOSIS

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“I had no symptoms,” Piccioli told Fox News Digital. “I’m one of those people who’s very diligent about my health and very cognizant about changes in my body. So for this to have happened without any signs or symptoms was just shocking to me.”

Because the cancer had already spread, it was automatically a stage 4 diagnosis.

Amy Piccioli, a Los Angeles mother of three, says she’s lucky to be alive after an uncommon procedure left her cancer-free. (Amy Piccioli)

“I just went numb — I couldn’t believe it,” Piccioli said. “Immediately, you have those feelings of panic and fear.”

In June 2024, Piccioli began undergoing chemotherapy, along with an immunotherapy drug. Just three months later, scans showed that the chemo had shrunk the tumors. Next, she underwent surgery to remove a tumor from her colon. 

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An unlikely path

After completing the traditional courses of treatment, Piccioli found herself embarking on a path to liver transplantation.

“The cancer was all over my liver,” she shared. “In cases where the cancer is confined to one side of the liver, they can basically cut that portion out … but in my case, a resection was not a possibility because the cancer was everywhere.” 

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Although the chemotherapy was successful, she said, “it was always going to be a ‘whack-a-mole’ situation, where I would be on systemic chemo for an extended period of time, new stuff would pop up, and it would just be this cycle over and over and again.”

“The chances of eradicating the cancer entirely from my liver with chemo alone was very slim. In cases like mine, liver transplantation is really the only long-term solution.”

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Piccioli (right) is pictured with Dr. Zachary C. Dietch, a transplant surgeon at Northwestern Medicine. (Northwestern Medicine)

Liver transplantation as part of a colorectal cancer treatment is more prevalent in Europe, but not common in the U.S.

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“We just didn’t think it would be an option here,” Piccioli said. “It seemed like something that was going to require a lot of effort to get.”

Her California care team soon discovered, however, that Northwestern Medicine in Chicago offers a liver transplantation program specifically for metastatic colorectal cancer patients.

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“I have no evidence of disease currently,” shared Piccioli, pictured on the beach with her husband and three kids. (Amy Piccioli)

“When liver metastasis is noted, our medical oncologists, along with our transplant surgeons begin to make care pathways tailored to the patient,” Satish Nadig, MD, PhD, transplant surgeon and director of the Northwestern Medicine Comprehensive Transplant Center, told Fox News Digital.

The chances of a successful transplant depend largely on how the patient responds to treatment, according to doctors. In “carefully selected” patients, the five-year survival rate can be 60% to 80%.

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“Response to chemotherapy is a critical gatekeeper for liver transplantation in colorectal liver metastases,” Nadig said.

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“Demonstrated disease control or response is usually required, as it identifies patients whose tumor biology (less aggressive and not spreading quickly) is favorable enough to justify a transplant.”

“You have to be the captain of your own ship.”

Piccioli, who was in search of a living donor, shared the need with family and friends. A lifetime childhood friend, Lauren Prior, underwent screening and was deemed a match.

The transplant was performed in December 2025, making Piccioli the first person at Northwestern to receive a living donor transplantation for metastatic colon cancer.

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Today, she and the donor are recovering well.

“The first week or two were difficult, but by week four, I was up and around, getting back to doing normal life things,” she said. “About two months out, I started working out again. I’m now three months out and feel completely normal. It’s amazing what the body can do.”

Piccioli, who was in search of a living donor, shared the need with family and friends. A lifetime childhood friend, Lauren Prior (right), underwent screening and was deemed a match. (Amy Piccioli)

Piccioli recently had her first post-transplant blood screening for tumor molecules within the body, and none were detected. “So I have no evidence of disease currently,” she shared. 

She will remain in Chicago for ongoing monitoring and screening until the end of March, when she will return home to Los Angeles.

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On the lookout

Early-onset colorectal cancer is often “silent,” according to Nadig.

“That’s because screening is absent before age 45 and symptoms (such as slow bleeding) are usually subtle,” he cautioned. Tumors can also grow in hard-to-detect locations, like the right side of the colon, or with biology that “delays obvious warning signs.”

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Although Piccioli experienced no warning signs, she encourages others to pay attention to any changes in the body that may signal cancer.

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“Do the screenings at the recommended ages, follow up and just be diligent about your health,” she advised. 

“I think a lot of the reason that I got to Northwestern and was able to receive this transplant was because I was so diligent about calling the doctors, scheduling the appointments … I think that is really the most important thing: You have to be the captain of your own ship.”

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Stopping Ozempic? New study reveals surprising weight regain results after GLP-1s

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Stopping Ozempic? New study reveals surprising weight regain results after GLP-1s

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With millions of people using injectable GLP-1 medications like Ozempic, Wegovy or Zepbound, many may wonder what happens if they stop.

Previous clinical trials suggested a discouraging “rebound” effect, where patients regained a significant portion of their lost weight almost immediately after ending treatment.

However, a new study from Cleveland Clinic, published in the journal Diabetes, Obesity and Metabolism, offers a more hopeful perspective on what happens when the injections stop.

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The study looked at nearly 8,000 adults in Ohio and Florida who used semaglutide or tirzepatide for three to 12 months before stopping, according to a press release.

Unlike tightly controlled clinical trials, the researchers looked at “real-world” outcomes where patients often switch from one medication to another.

Patients only regained a small portion of the overall weight they lost in the new study. (iStock)

Overall, patients did not experience significant weight regain in the year after stopping a GLP-1. Among those treated specifically for obesity, the average weight loss before stopping was 8.4%; one year later, they had regained just 0.5% on average.

“Our real-world data show that many patients who stop semaglutide or tirzepatide restart the medication or transition to another obesity treatment, which may explain why they regain less weight than patients in randomized trials,” said lead study author Dr. Hamlet Gasoyan in the press release.

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This suggests that the rebound seen in clinical trials may be a result of patients being left without alternative support, a scenario that doesn’t have to happen in clinical practice, researchers say.

An estimated 27% of patients transitioned to different medications, including older-generation obesity drugs, while another 20% eventually restarted their original medication once insurance issues or side effects were resolved.

An estimated 27% of patients transitioned to different medications. (iStock)

Another 14% transitioned to intensive lifestyle modification programs, working closely with dietitians and exercise specialists.

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Patients who maintained their weight tended to remain engaged with the healthcare system, whether through alternative prescriptions or structured lifestyle support, the researchers noted.

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There were some limitations to the study.

“We included adult patients from a single large integrated health system in Ohio and Florida,” the authors noted. “Patient characteristics and healthcare delivery patterns vary across the U.S., which may limit the generalizability of our findings.”

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Some of the observed weight reduction may be associated with other interventions that the team was unable to capture. (iStock)

Some of the observed weight reduction may be associated with other interventions that the researchers were unable to capture.

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“In our future work, we will examine the comparative effectiveness of alternative treatment options for obesity in patients who discontinue semaglutide or tirzepatide, to help patients and their clinicians make informed decisions,” Gasoyan added.

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