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Game-changing cholesterol pill wins FDA approval after cutting LDL nearly 60%

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Game-changing cholesterol pill wins FDA approval after cutting LDL nearly 60%

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Millions of Americans with high cholesterol now have a new treatment option, as the FDA has approved the first once-daily oral PCSK9 inhibitor.

Merck, the New Jersey-based manufacturer of Lipfendra (enlicitide), announced the approval on Thursday.

Lipfendra blocks the action of PCSK9, a naturally occurring protein that affects how the liver removes LDL (“bad”) cholesterol from the bloodstream.

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“PCSK-9 is a protein that works in the liver, preventing the recycling of LDL receptors, as a result increasing bad cholesterol in the blood,” Dr. Marc Siegel, Fox News senior medical analyst, told Fox News Digital.

Millions of Americans with high cholesterol now have a new treatment option, as the FDA has approved the first once-daily oral PCSK9 inhibitor. (iStock)

“In the caveman days, this was useful when we were hunter-gatherers and didn’t always have food, but now it mainly forms plaques that lead directly to heart disease.”

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The pill is approved as an add-on to diet and other LDL-lowering therapies in adults with high cholesterol, including inherited forms of high cholesterol, Merck stated.

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In phase 3 clinical trials, Lipfendra was shown to reduce LDL cholesterol by roughly 56% to 60% when combined with statin therapy.

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“This is around double the impact of statins,” Siegel noted.

The pill was generally well-tolerated in the trials, Merck reported. The most common side effects were diarrhea and dizziness, while serious side effects and treatment discontinuations occurred at rates similar to those in the placebo group.

The pill was generally well-tolerated in the trials, Merck reported. The most common side effects were diarrhea and dizziness, while serious side effects and treatment discontinuations occurred at rates similar to those in the placebo group. (iStock)

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Statins, which work by blocking an enzyme in the liver that the body uses to make cholesterol, are the most commonly prescribed cholesterol-lowering medications, according to the American Heart Association.

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For many people, statins are effective on their own. But for some patients who have very high cholesterol levels, inherited forms of high cholesterol or adverse side effects when taking statins, another medication — such as a PCSK9 inhibitor like Lipfendra — may be necessary, per the AHA.

Lipfendra blocks the action of PCSK9, a naturally occurring protein that affects how the liver removes LDL (“bad”) cholesterol from the bloodstream. (iStock)

Until now, PCSK9 inhibitors — such as Repatha and Praluent — have only been available as injections, a factor experts say may have contributed to their underuse.

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“Repatha, the injectable form, is very useful, with few side effects,” Siegel noted. “The oral form, Lipfendra, is also well-tolerated and just as effective.”

Additional research is needed to determine whether Lipfendra also reduces the risk of heart attacks, strokes and cardiovascular deaths. Results from a large clinical trial are expected to be available in 2029, Merck stated. (Merck & Co.)

Additional research is needed to determine whether Lipfendra also reduces the risk of heart attacks, strokes and cardiovascular deaths. Results from a large clinical trial are expected to be available in 2029, Merck stated.

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“Steve Nissen, longtime head of preventive cardiology at Cleveland Clinic, tells me that the lower the better when it comes to LDL cholesterol, especially in those at risk for heart disease,” Siegel added.

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Biden’s battle with advancing cancer renews focus on prostate disease

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Biden’s battle with advancing cancer renews focus on prostate disease

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Former President Joe Biden’s prostate cancer has spread further since his diagnosis last year, his son Hunter Biden revealed in a BBC interview that aired Friday.

“The cancer has spread, metastasized into his bones and further,” Hunter Biden told BBC Newsnight, describing his father’s condition as “very painful” and “very debilitating in many respects.”

“It’s really sad to watch,” the younger Biden went on. “The only thing that I’d say about my dad, about his health right now, is I wish he would complain more, because it’s not good.”

JOE BIDEN’S CANCER HAS SPREAD FURTHER, LEAVING HIM IN ‘VERY PAINFUL’ CONDITION, HUNTER REVEALS

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Biden, 83, announced his diagnosis in May 2025, after news that a “small nodule” had been found in the former president’s prostate during a routine exam.

“While this represents a more aggressive form of the disease, the cancer appears to be hormone-sensitive, which allows for effective management,” his office said at the time. “The president and his family are reviewing treatment options with his physicians.”

Former President Joe Biden’s prostate cancer has spread further since his diagnosis last year, his son Hunter Biden revealed. (Getty Images)

Biden later underwent hormone therapy and radiation treatment, completing a course of radiation at Penn Medicine Radiation Oncology in Philadelphia in October 2025, according to the former president’s spokesperson.

In addition to hormone therapy, common treatment options for prostate cancer include chemotherapy, targeted therapy, immunotherapy and radiopharmaceutical treatments.

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Fox News Digital reached out to Biden’s office for comment.

What to know about prostate cancer

Prostate cancer is a disease found in men that develops in the prostate gland. Cases have been on the rise in recent years, with overall incidence increasing about 3% annually from 2014 through 2021, according to the American Cancer Society.

Rates of advanced-stage prostate cancer rose about 5% per year during that period.

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About 333,830 new cases of prostate cancer are expected to be diagnosed in the U.S. in 2026, and about 36,320 men are expected to die from the disease, according to the American Cancer Society.

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One in eight men will be diagnosed with prostate cancer in their lifetime, the same source stated.

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Older men are at a higher risk of the disease, with six in 10 cases diagnosed in patients 65 and older. The average age at diagnosis is 67, with men under 40 rarely affected.

Prostate cancer is the second-most common cancer in men, behind only skin cancer, the ACS noted.

Signs and symptoms

Among men who undergo routine prostate cancer screening, the disease is usually caught early before symptoms emerge, per the ACS.

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Typical early symptoms include problems urinating, a weak or slow urinary stream or an increased need to urinate. Some men may also notice blood in the urine or bodily fluids.

Biden, 83, announced his diagnosis in May 2025, after news that a “small nodule” had been found in the former president’s prostate during a routine exam. (AP Photo/Jacquelyn Martin, File)

More advanced symptoms may occur after the disease has spread. Those may include pain in the hips, back (spine), chest (ribs) or other areas, the ACS stated.

Men may also suffer from erectile dysfunction, weight loss, extreme fatigue, weakness in the legs or feet, or loss of bladder or bowel control.

Screening recommendations

The U.S. Preventive Services Task Force states that men aged 55 to 69 years should have the option to undergo periodic prostate-specific antigen (PSA)-based screening to monitor for prostate cancer.

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“Before deciding whether to be screened, men should have an opportunity to discuss the potential benefits and harms of screening with their clinician and to incorporate their values and preferences in the decision,” the USPSTF states.

The U.S. Preventive Services Task Force states that men aged 55 to 69 years should have the option to undergo periodic prostate-specific antigen (PSA)-based screening to monitor for prostate cancer. (iStock)

While screening offers a “small potential benefit” of reducing the chances of dying from the disease, the agency noted that some men may experience negative effects, including false-positive results, overdiagnosis and overtreatment, and treatment complications.

Alternative prostate cancer screening methods are currently being researched, including one that uses a non-invasive urine test, as Fox News Digital recently reported.

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Survival rates

For localized prostate cancers, where the disease is contained within the prostate, the five-year survival rate is at least 99%, according to the ACS.

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For regional cases, where the disease has spread only to “nearby structures or lymph nodes,” the five-year survival rate is also 99% or greater.

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If the cancer has spread to other areas of the body, the five-year survival rate drops to 37%.

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Actual survival rates may vary based on the patient’s age, overall health, how the cancer has progressed post-diagnosis, the disease’s response to treatment, and other factors, the ACS noted.

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A DEXA Scan for Weight Loss Helped Her Lose 27 Pounds of Belly Fat

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A DEXA Scan for Weight Loss Helped Her Lose 27 Pounds of Belly Fat


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DEXA Scan for Weight Loss Helped Her Lose 27 Lbs of Belly Fat




















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Common marriage habit could quietly kill your sex life, expert warns

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Common marriage habit could quietly kill your sex life, expert warns

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Sexual desire can change over the course of a marriage, particularly with age and major life changes. And research suggests certain lifestyle and relationship factors may also contribute to a lower libido.

But changes in desire or frequency do not necessarily mean a couple’s sex life is unhealthy, according to experts.

Dr. Anna Elton, a licensed marriage and family therapist and clinical sexologist in Massachusetts, said there is “no medically prescribed number that defines a healthy sex life.”

HOW OFTEN ARE MARRIED PEOPLE HAVING SEX? WHAT TO KNOW ABOUT THE INTIMACY STANDARD IN AMERICA

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“What’s healthy is whether both partners feel connected, satisfied and respected in their intimate relationship,” she told Fox News Digital.

“For some couples, that may mean several times a week, while for others it may be once or twice a month. The healthiest benchmark is mutual fulfillment.”

There is no set benchmark for how often married couples should have sex, as long as both partners feel fulfilled, an expert said. (iStock)

Rather than comparing their sex lives to those of others, Elton encouraged couples to define what is healthy for their own relationship.

“Talk about what feels satisfying, how much time can pass before one or both of you starts feeling disconnected and what your warning signs are,” she said. “Once you’ve agreed on that range, make a commitment to maintain it together.”

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Elton advised couples not to let too much time pass without “intentionally reconnecting” because prolonged disconnection can take a toll on the relationship.

“If we simply wait until the mood is perfect or the stars align, work, children and everyday responsibilities usually get in the way,” she said. “Healthy relationships require intention. Both partners should share responsibility for initiating connection and creating the conditions where desire can develop.”

The expert advised couples not to let too much time pass without “intentionally reconnecting” because prolonged disconnection can take a toll on the relationship. (iStock)

For many couples, building careers, raising children, caring for aging parents, managing finances and juggling other responsibilities can demand more of their attention, and they may not realize that the relationship itself has become a low priority.

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“As a result, couples begin living parallel lives,” Elton told Fox News Digital. “Conversations revolve around schedules, errands, bills and the kids. Intentional time together becomes less frequent. Affection, physical touch, flirting and playfulness become less frequent, replaced by stress, conflict and growing resentment.

“For many couples, those changes are among the earliest signs that the relationship is no longer being intentionally nurtured, and sexual intimacy declines soon afterward.”

Less affection, physical touch, flirting and playfulness is an early sign that the relationship could be in danger. (iStock)

Elton countered that many couples she’s worked with continued to have sex regularly to “keep the peace or avoid conflict.” While their sex life appeared healthy from the outside, the couples felt “emotionally disconnected and unfulfilled.”

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“Physical intimacy and emotional closeness go hand in hand,” she said. “If we want to improve our sex lives, we have to focus on the connection itself.”

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“If one or both partners consistently feel rejected, lonely or resentful or avoid conversations about intimacy altogether, it’s time to seek help.”

If sex becomes painful or erectile difficulties arise or if hormonal concerns, trauma, depression, anxiety or persistent differences in desire are creating distress, couples should address these issues with a professional as early as possible, the expert advised.

If sex becomes painful or erectile difficulties arise – or if hormonal concerns, trauma, depression, anxiety or persistent differences in desire are creating distress – couples should address these issues with a professional as early as possible, the expert advised. (iStock)

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One of the most common concerns Elton sees in her practice is differences in sexual desire, which she confirmed is “completely normal.”

The key is to approach intimacy “as a team” because research has shown this leads to maintaining “stronger desire” over time.

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“Being responsive means staying curious about your partner’s experience,” she said. “Instead of pressuring or withdrawing, couples communicate openly, respect each other’s boundaries and work together to find an approach to intimacy that feels satisfying for both people.”

Couples should also broaden their definition of intimacy, Elton suggested, as general affection, physical touch, flirting, emotional closeness and intentional time together can “help partners feel more connected and create the conditions where sexual desire naturally returns.”

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