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FDA rejects MDMA as psychedelic-based treatment for mental health, PTSD

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FDA rejects MDMA as psychedelic-based treatment for mental health, PTSD

The U.S. Food and Drug Administration (FDA) announced Friday its rejection of MDMA as a treatment for PTSD.

The decision was based on “significant limitations” that “prevent the agency from concluding that the drug is safe and effective for the proposed indication,” the FDA stated, according to The Associated Press.

MDMA, also known as ecstasy or molly, is a psychedelic drug with effects that are similar to methamphetamine, according to the National Institute on Drug Abuse.

FDA PANEL REJECTS MDMA-ASSISTED THERAPIES FOR PTSD DESPITE HIGH HOPES FROM VETERANS

Veteran organizations have long been advocating for approval of psychedelic-assisted therapies to treat mental health challenges.

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The U.S. Food and Drug Administration announced Friday its rejection of MDMA as a treatment for PTSD. (iStock)

The FDA’s decision comes nearly eight weeks after an FDA advisory committee voted 10-1 against the overall benefits of MDMA in treating PTSD.

The FDA has requested another Phase 3 trial to confirm the drug’s safety and efficacy.

Lykos Therapeutics, the California company that filed the drug application, said it plans to meet with the FDA to appeal the decision, according to reports. 

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“The FDA request for another study is deeply disappointing, not just for all those who dedicated their lives to this pioneering effort, but principally for the millions of Americans with PTSD, along with their loved ones, who have not seen any new treatment options in over two decades,” Amy Emerson, the Lykos CEO, said in a statement from the company.

“While conducting another Phase 3 study would take several years, we still maintain that many of the requests that had been previously discussed with the FDA and raised at the Advisory Committee meeting can be addressed with existing data, post-approval requirements or through reference to the scientific literature.”

Veteran organizations have long been advocating for approval of psychedelic-assisted therapies for treating mental health challenges. (iStock)

An FDA spokesperson released a statement regarding the decision.

“As discussed at the Advisory Committee meeting, there are significant limitations to the data contained in the application that prevent the agency from concluding that this drug is safe and effective for the proposed indication.” 

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“The FDA request for another study is deeply disappointing, not just for all those who dedicated their lives to this pioneering effort, but for the millions of Americans with PTSD.”

— Lykos Therapeutics

Regarding the need for additional treatments for PTSD and other mental health conditions, the agency said it encourages further research and development to “further innovation for psychedelic treatments and other therapies to address these medical needs.”

PharmAla Biotech, a Toronto-based company focused on researching, developing and manufacturing novel derivatives of MDMA, reacted to the decision in a statement sent to Fox News Digital.

      

“USFDA has an important responsibility to get things right, and we believe that they are acting in good faith. However, there is a vitally important patient need for novel PTSD treatments, which must be balanced with that prudency,” said Nicholas Kadysh, CEO of PharmAla Biotech. 

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Ecstasy pills  (Reuters)

“MDMA is not only supported by a significant evidence base of published clinical trial research, but is also being actively used in patient treatments in two jurisdictions, Canada and Australia, entirely supplied by PharmAla.”

Kadysh added that the company is committed to ongoing research to “convince even the most skeptical regulators that this medicine is both safe and effective.”

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Joe Perekupka, CEO of Freespira, the Washington-based company that makes an FDA-approved digital therapeutic for PTSD and anxiety, also reacted to the decision.

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There have not been any new treatment options for PTSD in over two decades, according to a statement from Lykos Therapeutics. (iStock)

“The FDA’s recent decision on MDMA underscores the complex landscape of mental health treatments. At Freespira, we recognize the urgent need for additional effective PTSD treatments, but support the FDA’s commitment to patient safety when reviewing potential new treatments,” he said in a statement to Fox News Digital.

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“We believe in the importance of diverse treatment options and will continue to focus on our mission of democratizing access to advanced mental health care through our patient-centric model.”

Fox News Digital reached out to the FDA and to Lykos Therapeutics requesting comment.

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Flu hospitalizations hit all-time weekly high in densely populated state, officials warn

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Flu hospitalizations hit all-time weekly high in densely populated state, officials warn

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The New York State Department of Health has announced the highest number of flu hospitalizations recorded in a single week.

The state confirmed the uptick in hospital visits in a press release on Jan. 2, as flu cases continue to rise in the region and nationwide.

New York State, including New York City, has consistently tracked the highest numbers of recorded respiratory illness cases in the country for the last few weeks, according to CDC data. Several other states have climbed to the “very high” category for respiratory activity as well, as of the week ending Dec. 27.

RECORD-BREAKING FLU NUMBERS REPORTED IN NEW YORK STATE, SPARKING WARNINGS FROM OFFICIALS

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The most recent data from the New York health department showed a total of 4,546 hospitalizations from Dec. 26, 2025, to Jan. 2, 2026 – a week-over-week increase of nearly 1,000. The prior week, the department announced the highest number of flu cases ever recorded in a single seven-day period.

The New York State Department of Health reported a total of 4,546 hospitalizations from Dec. 26, 2025, to Jan. 2, 2026. (iStock)

In a statement, New York’s Acting Commissioner of Health Dr. James McDonald noted the severity of this flu season compared to previous years.

“Almost 1,000 more people were admitted to a hospital during this most recent seven-day period compared to the prior week,” he confirmed. “There is still time to get a flu shot, and remember, flu can be treated with antiviral medication if started within 48 hours of symptom onset [as] your doctor deems appropriate.”

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Health officials are pushing for Americans to consider getting the flu vaccine, as experts consider it to be a top line of defense for preventing viral exposure and spread.

Flu symptoms can include fever, chills, headache, fatigue, cough, sore throat and runny nose. (iStock)

In a previous interview with Fox News Digital, Dr. Neil Maniar, professor of public health practice at Boston’s Northeastern University, emphasized that it’s not too late to get the flu vaccine, as peak season typically occurs in January.

“The vaccine still provides protection against serious illness resulting from the subclade K variant that seems to be going around,” he said.

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Even healthy individuals can become seriously ill from the flu, Maniar noted, “so a vaccine is beneficial for almost everyone.”

“Individuals typically start to develop some degree of protection within a few days and gain the full benefit within about two weeks, so now is the time for anyone who hasn’t gotten the vaccine yet.”

“The vaccine still provides protection against serious illness resulting from the subclade K variant that seems to be going around,” one doctor said. (iStock)

Flu symptoms can include fever, chills, headache, fatigue, cough, sore throat and runny nose.

A mutation of influenza A H3N2, called subclade K, has been detected as the culprit in rising global cases, causing more intense symptoms and higher risk of spread.

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“It’s becoming evident that this is a pretty severe variant of the flu,” Maniar said. “Certainly, in other parts of the world where this variant has been prevalent, it’s caused some severe illness, and we’re seeing an aggressive flu season already.”

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New York State recommends taking preventive actions to avoid flu infection. These include washing hands often; avoiding touching the eyes, nose and mouth; avoiding close contact with sick people; cleaning and disinfecting objects and surfaces; and staying home when feeling sick.

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Not all cancers should be treated right away, medical experts say — here’s why

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Not all cancers should be treated right away, medical experts say — here’s why

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When someone gets a cancer diagnosis, the initial reaction is usually to undergo treatment as quickly as possible — but for some types of disease, doctors may recommend a more conservative approach.

For certain cancers, immediate or aggressive treatment can cause more harm than good, according to multiple medical experts.

For example, treating slow-growing tumors with surgery, radiation or chemotherapy could create significant side effects without a survival benefit.

PROSTATE CANCER PATIENTS SEE LONGER SURVIVAL WITH NEW COMBINATION DRUG 

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“The fact that so many cancers will never kill you is not a justification for not knowing, because there is still plenty of room for ‘watchful waiting,’ as well as interventions that may improve quality of life even if they don’t extend life,” Dr. Marc Siegel, Fox News senior medical analyst, told Fox News Digital.

This is especially true as targeted cancer treatments emerge, which are more personalized and less likely to cause severe side effects, according to the doctor.

For precancerous, very early-stage breast conditions, careful monitoring may be more prudent than immediate surgery, research shows. (iStock)

“The fact that cancers are occurring earlier is a justification for heightened screenings, not the opposite,” Siegel added. “Information is power — what you do with that information is based on clinical judgment and the art of medicine.”

Below are some types of cancer that may not warrant treatment, according to research and doctors’ guidance.

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No. 1: Prostate cancer (low-risk)

While some types of prostate cancer should be treated right away, others are better addressed by “watchful waiting,” according to Sanoj Punnen, M.D., a urologic oncologist with Sylvester Comprehensive Cancer Center, part of the University of Miami Health System. 

“With respect to prostate cancer, for most low-risk cancers (Gleason 6 or grade group 1), we recommend initial observation and surveillance rather than immediate treatment,” he told Fox News Digital.

NEW PROSTATE CANCER TEST PINPOINTS DISEASE BETTER THAN PSA OPTION, STUDY FINDS

The Gleason score is a grading system that ranks prostate cancer cells in terms of how abnormal they are, with 6 being the lowest grade and 10 being the highest grade (barely resembling normal cells).

“For high-grade tumors like Gleason 8, 9 or 10, we believe they progress quickly, so we recommend treatment to prevent the risk of metastasis,” said Punnen, who is also vice chair of research and a professor with the Desai Sethi Urology Institute at UHealth. “For low-risk tumors, we think they pose little risk, so we recommend just observation.”

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“The fact that cancers are occurring earlier is a justification for heightened screenings, not the opposite.”

“But in the end, we can’t be sure, so our approach to observation includes serial monitoring of cancer status with PSA, MRI and occasional biopsy to ensure the tumor isn’t progressing.”

No. 2: Ductal carcinoma in situ (DCIS) 

Also known as stage 0 breast cancer, DCIS is a non-invasive disease marked by abnormal cells in the lining of the breast milk ducts. The “in situ” is Latin for “in the original place,” which indicates that the cancer has not spread outside the milk ducts.

For this precancerous, very early-stage breast condition, careful monitoring may be more prudent than immediate surgery, research shows.

While some types of prostate cancer should be treated right away, others are better addressed by “watchful waiting,” according to a urologic oncologist. (iStock)

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A 2024 study by the Dana-Farber Cancer Institute found that active monitoring for DCIS resulted in similar quality of life, mental health and symptom progression over a two-year period compared to a standard surgical approach.

NEW STUDY QUESTIONS WHETHER ANNUAL MAMMOGRAMS ARE NECESSARY FOR MOST WOMEN

“These results suggest that in the short term, active monitoring is a reasonable approach to management of low-risk DCIS,” the lead researcher said in a press release. “If longer-term follow-up supports the safety of active management from a cancer outcome standpoint, this approach could be considered as an option for women with this condition.”

“But it is also critical that we understand how women feel when they are living with this ‘watch and wait’ approach and how it impacts their overall quality of life.”

Other research has suggested that women with low-risk DCIS did not have a higher rate of invasive cancer after two years of active monitoring, although each patient should discuss their individual risk level with an oncologist.

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No. 3: Indolent (slow-growing) lymphomas

Non-Hodgkin lymphoma (NHL) is a type of cancer that starts in the lymphatic system, which includes the lymph nodes, spleen, thymus, bone marrow and other tissues. 

Indolent lymphomas are those that “grow and spread slowly,” according to the American Cancer Society.

THE DEADLY CANCER HIDING IN PLAIN SIGHT — AND WHY MOST PATIENTS NEVER GET SCREENED

The National Comprehensive Cancer Network (NCCN) recommends watchful waiting for asymptomatic, slow-growing follicular lymphoma, as a means of avoiding the toxicity of chemotherapy and immunotherapy until it’s absolutely necessary.

The Lymphoma Research Foundation confirms that doctors recommend “active surveillance” for some patients with slow-growing lymphoma.

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Indolent lymphomas are those that “grow and spread slowly,” according to the American Cancer Society. (iStock)

“This approach may be started after the initial diagnosis or after relapse, depending on the situation,” the foundation states on its website. “Active treatment is started if the patient begins to develop lymphoma-related symptoms or if there are signs that the disease is progressing.”

Treatment should be started right away for aggressive (fast-growing) lymphomas.

No. 4: Chronic lymphocytic leukemia

One of the most common adult leukemias, chronic lymphocytic leukemia (CLL) originates in white blood cells (lymphocytes) in the bone marrow and then spreads to the bloodstream, according to the American Cancer Society.

CLL tends to grow slowly, with many patients experiencing no symptoms for years. Eventually, the cancer calls can spread to the lymph nodes, liver and spleen.

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BREAKTHROUGH BLOOD TEST COULD SPOT DOZENS OF CANCERS BEFORE SYMPTOMS APPEAR

Some studies have shown that early treatment for CLL does not improve survival rates compared to observation, and that the benefits may not outweigh the risks.

In a 2023 study presented at the European Hematology Association 2023 Congress in Frankfurt, Germany, researchers found that early treatment did not prolong overall survival compared to a placebo in patients with early, asymptomatic CLL.

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“I believe it’s fair to conclude that ‘watch-and-wait’ should remain the standard of care in the era of targeted drugs,” said researcher Petra Langerbeins, M.D., when presenting the findings.

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No. 5: Low-grade endometrial cancer

For most patients with endometrial cancer, surgery is the first treatment, which entails removing the uterus, fallopian tubes and ovaries, according to the American Cancer Society.

However, in certain patients with low-grade cancer, such as older people, those with “frailty” and people with major health issues, doctors may recommend deferring surgery, which can pose a high risk.

The American Thyroid Association’s guidelines officially recommend active surveillance for very low-risk microcarcinomas. (iStock)

In cases where the patient has medical comorbidities or wants to preserve fertility, hormone treatment may be used instead of surgery, per the ACS.

“It’s usually also considered for cancer that is lower-grade, low-volume and slow-growing,” the above source stated.

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No. 6: Some early kidney cancers

In cases of kidney cancer with small tumors (≤3 cm) or benign lesions, doctors may recommend monitoring them instead of undergoing surgery for removal.

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The American Urological Association confirms that active surveillance is an option for some small renal masses (localized tumors).

“I believe it’s fair to conclude that ‘watch-and-wait’ should remain the standard of care in the era of targeted drugs.”

Deferred treatment is particularly recommended for older patients or those with “significant comorbidities,” research shows.

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“Shared decision-making about active surveillance should consider risks of intervention/competing mortality versus potential oncologic benefits of intervention,” the UAU states in its guidance.

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Data from the Delayed Intervention and Surveillance for Small Renal Masses (DISSRM) Registry showed that patients with active surveillance had a 99% or greater cancer-specific survival rate — virtually the same as patients who received immediate treatment.

No. 7: Small papillary thyroid cancers

Papillary thyroid cancer (PTC), the most common type of thyroid cancer, may not warrant treatment for small tumors measuring 1 centimeter (10 mm) or less, which are called microcarcinomas.

A young multiracial female is undergoing a diagnostic medical imaging procedure in a state-of-the-art hospital setting with CT simulator. The image illustrates the use of cutting-edge technology for healthcare and treatment in a modern medical environment. The portrayal highlights precision, care, and the sophistication of contemporary medical practices. (iStock)

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Research found that when using active surveillance for 10 to 20 years, less than 10% experienced significant growth, only 5% developed lymph node spread and there were no thyroid-cancer deaths.

The American Thyroid Association’s guidelines officially recommend active surveillance for very low-risk microcarcinomas.

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While many patients with low-risk tumors can safely delay treatment, this does not apply to all cancers or all patients. 

As cancer behavior and personal health factors vary widely, patients should consult their doctor to determine the most appropriate course of care based on their individual risk level.

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Brain Health Challenge: Test Your Knowledge of Healthy Habits

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Brain Health Challenge: Test Your Knowledge of Healthy Habits

Welcome to the Brain Health Challenge! I’m Dana Smith, a reporter at The New York Times, and I’ll be your guide.

To live a healthy life, it’s crucial to have a healthy brain. In the short term, it keeps you sharp and firing on all cylinders. In the long term, it can reduce your risk of cognitive decline, dementia and stroke.

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Practicing basic healthy behaviors, like eating nutritious food and getting regular exercise, is the best way to enhance your brain power and protect the longevity of your neurons. These types of lifestyle habits can benefit the brain at any age. And while they won’t guarantee that you’ll never develop dementia or another brain disease, several clinical trials have shown that they can improve cognition or slow decline.

Every day this week, you’ll do an activity that’s good for your brain, and we’ll dig into the science behind why it works. Some of these activities can provide a small immediate cognitive benefit, but the bigger reward comes from engaging in them consistently over time. So along with the neuroscience lessons, we’ll include a few tips to help you turn these actions into lasting habits.

To keep you accountable, we’re encouraging you to complete this challenge with a friend. If you don’t have a challenge buddy, no problem: We’re also turning the comments section into one big support group.

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There are so many fascinating ways your daily behaviors affect your brain. Take sleep, for example.

Lots of studies have shown that getting a good night’s rest (seven to eight hours) is associated with better memory and other cognitive abilities. That’s because sleep, especially REM sleep, is when your brain transfers short-term memories — things you learned or experienced during the day — into long-term storage.

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Sleep is also when your brain does its daily housekeeping. While you rest, the brain’s glymphatic system kicks into high gear, clearing out abnormal proteins and other molecular garbage, including the protein amyloid, which is a major contributor to Alzheimer’s disease. A buildup of amyloid is one reason experts think that people who routinely get less sleep have a higher risk of dementia.

What other behaviors play a big role in brain health? For today’s activity, we’re going to test your knowledge with a quiz. Share your score with your accountability partner and in the comments below — I’ll be in there too, cheering you on.

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