Health
FDA Approved Artificial Blood Vessel Despite Warnings
When the biotech company Humacyte designed a study to see if its lab-grown blood vessel worked, it decided to measure whether blood was flowing freely through the high-tech tube 30 days after it was implanted in a person.
As those days passed, some of the 54 patients in the study ran into trouble. Doctors lost track of one. Four died. Four more had a limb amputated, including one who developed a clot and infection in the artificial vessel, Food and Drug Administration records show.
Humacyte, which is traded on the Nasdaq, counted all those patients as proof of success in talks with investors and in an article in JAMA Surgery.
At the F.D.A., though, scientists counted the deaths, amputations and the lost case as failures, records show, noting a lack of information to determine if the vessels were clear.
Still, the agency approved the vessels in December without a public review of the study. Top officials authorized it over the concerns of staff members who said in F.D.A. records that they found the study severely lacking or were alarmed by the dire consequences for patients when the vessels fell apart.
Now the company is ramping up its marketing efforts to hospitals and for use on the battlefield.
When a patient’s blood vessel is damaged, doctors typically find a blood vessel from another part of the body and graft it to repair blood flow. They turn to artificial vessels when patients are too badly injured to harvest a vein.
The Humacyte vessel is made from a mesh tube seeded with cells from the human heart. The cells grow over two months in a bioreactor, and at the end of the process, the human cells and genetic material are removed. A lab-grown tube, mostly made of collagen developed from the aortic cells, remains.
Before the vessel was approved, one F.D.A. medical reviewer pointed out that 37 of the 54 patients were not assessed in a safety check four months after getting the implant, with many dead or lost to follow-up. “There is significant uncertainty regarding the safety and effectiveness of this product beyond 30 days,” the F.D.A. report says.
Dr. Robert E. Lee, a vascular surgeon who cared for gunshot-wounded patients in Detroit for 30 years, retired in the fall from the F.D.A. in protest over the matter. In a review of more than 2,000 pages of company records conducted when he was an F.D.A. medical officer, Dr. Lee found that the vessel could rupture with no warning. Those events were “unpredictable, catastrophic and life-threatening,” he wrote in his F.D.A. review, parts of which were made public weeks ago.
“That’s an unacceptable risk for whatever slim benefit, if any, this product provides above the current standard treatments,” Dr. Lee, who had been a reviewer at the agency since 2015, said in an interview. He noted that doctors currently use the patients’ own vessels, if available, or tubes made of Gore-Tex.
An F.D.A. spokeswoman said the approval “was based on a careful evaluation of data from clinical trials that demonstrated a clinically meaningful benefit in restoring blood flow in the affected limb and ultimately limb salvage.”
Humacyte is also developing a graft for patients with dialysis, for those undergoing cardiac bypass surgery and for infants with a heart-related birth defect.
Dr. Laura Niklason, one of the company’s founders, said approval of the vessel, called Symvess, was a “milestone for regenerative medicine overall.”
She had begun work to create the lab-grown vessels decades earlier. In its 20 years, the company had logged no sales and accrued more than $660 million in debt, financial reports show.
In an interview, Dr. Niklason said the disagreement over how to label the patient deaths and amputations as successes or failures arose after the company decided to count cases as failures only when it was certain that blood flow was cut off. The F.D.A. took a more conservative approach to calculating the success rate for the product, she said. “Rational people can disagree,” she added.
The F.D.A. records do not indicate whether the problems with the vessels directly caused the deaths or amputations.
Dr. Niklason said that the company must use the agency numbers in marketing the product to clients but that it could present its more favorable figure to investment analysts. She also said the study was published before the F.D.A. reached its decision.
B.J. Scheessele, the company’s chief commercial officer, told investors this month that Humacyte was in talks with 26 hospitals to begin distribution. Mr. Scheessele also said the company was hoping to sell the vessels to the Defense Department for battlefield injuries. The U.S. Army gave Humacyte $6.8 million in 2017, embracing the product as an option for wounded soldiers.
Each artificial vessel costs $29,500, and Mr. Scheessele said the company hoped to market several thousand each year in the United States.
Dr. Niklason said in an interview that her interest in engineering a blood vessel was twofold. As a young doctor, she had observed that arterial disease was devastating.
She described an experience as a medical resident in the late 1990s watching a senior doctor make incision after incision in a patient’s legs and arm, seeking a healthy vessel to use in a heart bypass surgery. She called the procedure “barbaric.”
“To provide a new blood vessel for a patient who needs one, we usually have to rob Peter to pay Paul,” she said.
Since Dr. Niklason first began meeting with the F.D.A. in 2015 about starting a trial in humans, the agency repeatedly found fault with the company’s efforts to study the vessel’s use. Its trial involved people suffering major trauma, such as gunshot or car crash injuries, took place in U.S. hospitals and in Israel. The participants had an average age of 30, and half were Black patients.
Humacyte also provided the vessels to doctors treating injured soldiers in Ukraine.
By Nov. 9, 2023, Dr. Niklason described results of the studies to investors on an earnings call in glowing terms. Initially, she said the rate of blood flow through the vessels at 30 days was 90 percent — beating existing products on the market.
And the results in Ukraine were “remarkable,” she said. “We’re proud to be able to help our Ukrainian surgeon colleagues save life and limb in this wartime setting.”
Over the ensuing months, though, reviewers at the F.D.A., including Dr. Lee, would examine the same studies and conclude that they did not look nearly as good.
As a vascular and general surgeon in Detroit, Dr. Lee had decades of experience with victims of gunshots, stabbings, car crashes and other accident victims who might receive such vessels.
He said he was alarmed by the account of a man in Ukraine who began bleeding at the site of his surgical wound eight days after the vessel was implanted. Doctors discovered a two-millimeter hole in the Humacyte vessel and repaired it with sutures, according to F.D.A. records. Four days later, the patient was bleeding again, requiring removal of the graft the next day. The review suggested that an infection could have played a role.
Of 71 cases that Dr. Lee examined for a safety review, seven people, or about 10 percent, experienced vessel failures that resulted in major bleeding, according to the F.D.A. review. Dr. Lee said that was unheard-of in his experience with Gore-Tex grafts.
“Plastic arteries, they don’t usually present with catastrophic hemorrhage, unexpected like this,” Dr. Lee said. “You know the patients are sick,” with a fever or other signs of an infection, he continued. “You know something’s brewing, and you usually have time to take care of it.”
Hoping to glean more information about the root cause of the mid-vessel blowouts — and to be sure doctors were aware of the possibility — Dr. Lee began seeking a public advisory hearing on the device.
Thomas Zhou, a biostatistician in the biologics division of the F.D.A., also flagged concerns from the U.S. arm of the study and the data from Ukraine.
“Neither study met the usual criteria for an adequate and well-controlled trial,” he wrote.
The study of 16 patients treated in Ukraine was retrospective and observational, meaning researchers could look back at a larger pool of data and select the best cases. It showed “limited support of efficacy,” partly because the injuries were “skewed to shrapnel injuries” and not the devastating wounds typically seen on the battlefield, he said.
The U.S. study was “poorly conducted” and underwent “multiple major changes” during the trial, the statistical review said.
The records also show that F.D.A. scientists dismissed as successful the patient deaths and amputations, citing a lack of information or imaging studies.
As a result, the F.D.A. concluded that the vessel’s success rate for that key study was 67 percent, rather than the company’s 84 percent, F.D.A. records show. In comparison, artificial grafts already had blood flow rates of 82 percent, the review said.
The company also reported an 84 percent success rate at 30 days in an article published in November in JAMA Surgery, which is widely read by surgeons. The article stated that the Humacyte vessel “demonstrates improved outcomes” over other artificial vessels.
It also said the Symvess “provides benefits” in “infection resistance.” The F.D.A. review said there was no clinical evidence demonstrating that extra effect.
Dr. Lee failed to persuade top F.D.A. officials to hold a public advisory committee meeting where the study results could be discussed and reviewed by independent experts. The agency decided instead to send records to three external reviewers, who in turn identified failure of the Humacyte vessels “as a serious risk,” but added that “the appropriate patient population” would benefit, according to documents.
In announcing approval of the graft on Dec. 20, Dr. Peter Marks, head of the biologics division, called the vessels “innovative products that offer potentially lifesaving benefits for patients with severe injuries.”
But the product is accompanied by a black box warning — the agency’s most serious — for failures that “can result in life-threatening hemorrhage.” The F.D.A. also is requiring the company to continue reporting safety data.
Dr. Hooman Noorchashm, co-director of the Amy J. Reed Medical Device Safety Collaborative at Northeastern School of Law, said the F.D.A. should not have approved a product that its scientists deemed inferior to existing options.
“If the graft falls apart,” he said, or if it disconnects to where it is attached to the vessel, “it is basically akin to the patient getting shot.”
Dr. Lee said he hoped the F.D.A., with new leadership under the Trump administration, would still hold a public meeting.
“Every surgeon who uses it needs to see the things that I did,” he said.
NEWYou can now listen to Fox News articles!
Researchers found unusually high hantavirus levels in rodents in the Pacific Northwest, suggesting greater exposure risk in the surrounding agricultural communities.
The area with the biggest prevalence is the Palouse region, which includes parts of eastern Washington and north-central Idaho in the Pacific Northwest.
Researchers from Washington State University’s College of Veterinary Medicine found unexpectedly high levels of Sin Nombre virus (SNV), which is the strain most strongly linked to hantavirus pulmonary syndrome (HPS) — among local rodent populations.
WHAT IS HANTAVIRUS, THE CAUSE OF GENE HACKMAN’S WIFE’S DEATH?
In summer 2023, they collected samples from 189 deer mice, voles and chipmunks at eight farms and two forest sites.
Nearly 30% of sampled rodents showed evidence of prior exposure and about 10% had active infections, according to the study press release. The rodents that tested positive were from both agricultural environments (farms) and natural settings (wilderness).
Researchers found unusually high hantavirus levels in rodents in the Pacific Northwest, suggesting greater exposure risk in the surrounding agricultural communities. (iStock)
While deer mice are the primary carriers of hantavirus pulmonary syndrome, the researchers found infections across multiple rodent species.
This suggests that Sin Nombre virus may be more widespread in the region than previously thought.
HANTAVIRUS FEARS SPARK COVID FLASHBACKS, BUT EXPERTS SAY THERE’S ONE MAJOR DIFFERENCE
The findings were published in 2026 in Emerging Infectious Diseases, a peer-reviewed journal from the Centers for Disease Control and Prevention.
“We were surprised both by how common the virus was locally and by how little data existed for the Northwest,” said Stephanie Seifert, the study’s corresponding author and principal investigator of the Molecular Ecology of Zoonotic and Animal Pathogens lab in the College of Veterinary Medicine’s Paul G. Allen School for Global Health, in the press release.
“We’re really just beginning to understand how widespread and complex this virus is in rodent populations here.”
The hantavirus detected in this study is different from the Andes virus, the strain linked to the recent outbreak on board the MV Hondius cruise ship. (Getty Images)
The Sin Nombre virus, the most common hantavirus in the U.S., is typically spread to humans through inhalation of aerosolized rodent urine, droppings or saliva and is not known to spread person-to-person.
This is different from the Andes virus, the strain linked to the recent outbreak on board the MV Hondius cruise ship. Andes virus is the only hantavirus that is capable of spreading between people through close, prolonged contact.
“People may be exposed more often than we realize, but severe cases are more likely to be tested for hantavirus.”
Dr. Sonja Bartolome, an expert in pulmonary and critical care at UT Southwestern Medical Center in Dallas, pointed out that since national tracking began in 1993, the illness has remained rare, with 864 cases reported between 1993 and 2022.
POSSIBLE HANTAVIRUS CASE UNDER INVESTIGATION IN UPSTATE NEW YORK; NO CONNECTION TO DEADLY CRUISE SHIP OUTBREAK
“Most cases have occurred in Colorado, New Mexico and Arizona, and 94% have been reported in states west of the Mississippi River,” Bartolome, who was not involved in the study, told Fox News Digital.
CLICK HERE FOR MORE HEALTH STORIES
“It is important to conduct research that expands our understanding of how the virus spreads,” she went on. “Studies like this – which obtain and compare viral genetic sequences across regions and animals – help clarify how the virus moves geographically and between species.”
The researchers recommend efforts to prevent rodent exposure for living and farming in rural areas. (AP Photo/Godofredo A. Vásquez, File)
Although similar findings have been reported in other regions, this is the first study to reveal the pattern in this part of the country, Bartolome noted.
“Because humans most commonly contract hantavirus through exposure to aerosolized rodent urine or droppings, precautions remain essential when cleaning areas with evidence of rodent activity,” she added.
CLICK HERE TO SIGN UP FOR OUR HEALTH NEWSLETTER
The study presented some limitations, primarily that it only measured the infection in rodents and did not evaluate human transmission risk.
Additionally, the samples were only taken in the Palouse region and may not be generalized to all the Pacific Northwest.
CLICK HERE TO DOWNLOAD THE FOX NEWS APP
The research was also conducted during a single season, which means the conclusions don’t reflect year-round data.
The study suggests the need for expanded hantavirus monitoring in the Pacific Northwest, especially in agricultural areas.
The study presented some limitations, primarily that it only measured the infection in rodents and did not evaluate human transmission risk. (iStock)
The researchers recommend efforts to prevent rodent exposure for living and farming in rural areas. Longer-term studies could help clarify how environmental conditions and seasonal changes affect prevalence of the virus, they added.
TEST YOURSELF WITH OUR LATEST LIFESTYLE QUIZ
“People may be exposed more often than we realize, but severe cases are more likely to be tested for hantavirus,” said Pilar Fernandez, a co-author on the study and a disease ecologist in the Allen School whose research focuses on the eco-epidemiology of zoonotic diseases, in the release.
“Understanding that gap — how exposure translates into disease — is the next big step.”
NEWYou can now listen to Fox News articles!
How long you sleep could be linked to how long you’ll live.
A new study, published in the journal Nature, found that people who slept too little or too long showed signs of “older biology.”
Researchers from Columbia University in New York used global biobank data from about 500,000 people who disclosed self-reported sleep duration in a 24-hour period, including naps.
DEEP SLEEP CAN KEEP TWO BIG HEALTH PROBLEMS AT BAY, NEW STUDIES SUGGEST
Reported sleep times were compared with 23 biological aging clocks, estimating whether various parts of the body looked biologically older or younger than the individual’s actual age.
Short and long sleep were both linked with signals of a higher biological age. They were also associated with a higher risk of future diseases and all-cause mortality, the researchers found.
According to study results, short sleep and long sleep were both linked with signals of higher biological age. (iStock)
In nine of the aging clocks, the researchers found “statistically significant” links between sleep and aging, including in the brain, heart, immune system and skin.
Those with the “lowest biological age gap” were women who slept for 6.5 to 7.8 hours and men who slept for 6.4 to 7.7 hours, according to the study.
Longer sleep had a stronger link to psychiatric-related outcomes, while short sleep had more physical impacts on cardiovascular, metabolic, musculoskeletal, psychiatric, neurological, pulmonary and gastrointestinal conditions.
HERE’S WHY 90% OF AMERICANS DON’T SLEEP THROUGH THE NIGHT, ACCORDING TO EXPERT
The U-shaped results also showed that shorter sleep led to a 50% higher relative risk for all-cause mortality, while longer sleep had about a 40% higher risk.
The researchers noted that self-reported sleep poses a limitation to the study. As it was observational in design, it does not prove that sleeping exactly six to eight hours will slow aging.
Both women and men who slept roughly six to eight hours showed the lowest signals for biological aging. (iStock)
Saema Tahir, MD, a New York-based board-certified sleep medicine physician, reflected on these findings in an interview with Fox News Digital.
“Sleep is really when the body does its most critical repair work, including cellular restoration, immune regulation, hormonal balance, and even clearing out metabolic waste from the brain through what we call the glymphatic system,” said Tahir, who was not involved in the study.
AGING PROCESS COULD ACCELERATE DUE TO ‘FOREVER CHEMICALS’ EXPOSURE, STUDY FINDS
“When sleep is consistently too short or too long, those processes get disrupted. Over time, that disruption accumulates at the cellular level.”
This effect is proven in increased inflammatory markers and cellular changes, which are “hallmarks of accelerated aging,” Tahir noted.
“So, the relationship isn’t just correlational; there are real physiological mechanisms connecting poor sleep to the body aging faster than it should.”
“Sleep is really when the body does its most critical repair work,” the doctor noted. (iStock)
Tahir cautions her patients not to treat the six- to eight-hour recommendation as a “rigid prescription,” as sleep is individualized.
For example, a healthy 25-year-old and a 70-year-old with cardiovascular disease have “very different sleep architecture and needs,” according to the expert.
DO WOMEN NEED MORE SLEEP THAN MEN? HERE’S WHAT EXPERTS THINK
“What I tell my patients is to use that range as a starting framework, but pay attention to how you feel,” she advised. “Are you waking up refreshed? Can you stay alert throughout the day without caffeine propping you up? Those functional cues matter just as much as the number on the clock.”
For certain people, like pregnant women, athletes and people recovering from illness, these sleep needs can shift “considerably.”
As sleep is individualized, a rigid six- to eight-hour framework may not work for everyone. (iStock)
“Sleep duration is important, but … getting adequate sleep and REM sleep that allows our bodies to heal, clear, process and repair is much more important,” Tahir said.
Regardless of sleep time, those who don’t achieve quality sleep often struggle, she shared.
CLICK HERE FOR MORE HEALTH STORIES
“I’ve seen patients who log seven hours but spend most of that time in light sleep, barely touching the deep slow-wave or REM stages that are most restorative,” Tahir said. “They age just as poorly, sometimes worse, than someone getting six hours of genuinely consolidated, high-quality sleep.”
Deep sleep is the phase when growth hormone is released and tissue repair peaks, and REM sleep is “critical” for cognitive health and emotional regulation, according to the expert.
CLICK HERE TO SIGN UP FOR OUR HEALTH NEWSLETTER
“So, chasing hours without addressing sleep fragmentation, sleep apnea or poor sleep architecture is missing the bigger picture,” she said.
The takeaway from this study, according to Tahir, is that sleep is not a “lifestyle luxury,” but a “biological necessity with measurable consequences for how we age and how healthy we are.”
CLICK HERE TO DOWNLOAD THE FOX NEWS APP
There’s still a cultural tendency to see sleep deprivation as a “badge of productivity,” which she pushes back against. “But I also want people to avoid the other extreme — health anxiety about their sleep can actually make sleep worse.”
TEST YOURSELF WITH OUR LATEST LIFESTYLE QUIZ
The sleep expert concluded that “consistent, good-quality sleep is one of the most accessible tools we have for healthy aging.”
“It doesn’t require a prescription or expensive intervention — it requires prioritization.”
NEWYou can now listen to Fox News articles!
As GLP-1 weight-loss medications gain traction, the peptide market is experiencing a surge in interest.
A variety of peptides — commonly marketed for weight loss, muscle building, injury recovery and other uses — have emerged as largely unregulated drugs sold through both licensed compounding pharmacies and unverified vendors.
The U.S. Food and Drug Administration is set to evaluate whether to loosen regulations on several peptides during a meeting this summer.
THINKING ABOUT PEPTIDES? DOCTORS REVEAL KEY DOS AND DON’TS AS ‘WILD WEST’ MARKET GROWS
Peptides are short chains of amino acids — the building blocks of proteins — that play key roles in biological functions, according to the National Institutes of Health. Peptide drugs are lab-made versions of natural molecules in the body that are designed to mimic or influence biological signals to treat disease, experts say.
GLP-1s are “incredibly effective at what they do when it comes to changing body composition, benefiting metabolic health, cardiovascular health [and] neurologic health,” the expert said. (iStock)
Though the peptide market has been described as the “Wild West,” demand remains strong, potentially challenging pharmaceutical giants that dominate the GLP-1 market.
Dr. Alex Tatem, an Indiana-based board-certified urologist with expertise in men’s health and peptides, discussed how “life-changing” GLP-1s kicked off the rise of peptides.
“These were all medications that were designed to help people live well and live as healthy as possible.”
“They are incredibly effective at what they do when it comes to changing body composition, benefiting metabolic health, cardiovascular health [and] neurologic health,” he said. “These are truly miracle compounds, and as a result we’ve seen an explosion of interest – not just on the pharmaceutical side or the doctor’s side, but from the general public.”
According to Tatem, the challenge is that nearly all commercial GLP-1 products are administered in a single-dose weekly pen, which works for the “overwhelmingly majority” of patients, but not for everyone.
OZEMPIC ‘MICRODOSING’ IS THE NEW WEIGHT-LOSS TREND: SHOULD YOU TRY IT?
“There are patients I can prescribe tirzepatide to and they can do OK with a once-a-week [dose], but they end up developing nausea with that initial injection – and then by the end of the week, they’re hungry again.”
Because some patients respond better to smaller, more frequent doses — an option not offered by commercial drugs — compounding, or the customization of medications, has grown in popularity, Tatem said.
Several GLP-1 weight loss medications have been approved by the FDA with positive results from consumers. (iStock)
“We’ve had compounding pharmacies that have now developed compounded versions of semaglutide and tirzepatide that allow that sort of dosing flexibility,” he said.
“The reason compounders had to do this was because there was so much demand for GLP-1s that there was actually a national shortage.”
Current legislation allows compounders to step in during widespread national shortages, according to Tatem, prompting the industry to invest millions of dollars into developing and manufacturing these drugs.
PEPTIDES MAY SOON BE EASIER TO GET AMID RFK JR.’S PUSH, BUT EXPERTS WARN OF RISKS
Once commercial pharmaceutical companies could catch back up, compounders continued making these medications in smaller batches for custom doses, allowing for more patient accessibility.
“That creates a huge clash between commercial pharmaceutical companies and compounders, because commercial pharmaceutical companies view that as an infringement of their property,” Tatem noted.
The expert noted a “huge clash” between pharmaceutical companies and compounding pharmacies in peptide production. (iStock)
Tatem raised concerns about the FDA’s regulation of compounding pharmacies, warning that it could limit patients’ access to customized medications.
“That is a real concern for clinicians like me who really care more about patient access, making sure we can get the right medication to the right patients at the right time,” he said.
RFK JR. BACKS EASIER PEPTIDE ACCESS FOR WELLNESS AS DOCTORS RAISE RED FLAGS
Some peptides have been widely administered for more than a decade without major health complications like toxicity or cancer, according to Tatem.
“These are compounds that haven’t gone through the full FDA approval process that you would normally see for a commercial drug, [yet] we didn’t see anything adverse,” he said.
The FDA plans to consider loosening restrictions on several peptides during a summer 2026 meeting. (Issam Ahmed/AFP)
In September 2023, the FDA “quietly” tightened regulation of 19 peptides, making them illegal to manufacture and cutting off patient access.
“They seemed to be working and seemed to be efficacious for patients, and all of a sudden they were banned, which inadvertently ended up contributing to this surge in interest,” Tatem said. “We kind of saw the same thing happen with peptides that we saw with prohibition.”
CLICK HERE FOR MORE HEALTH STORIES
While the rising popularity of GLP-1 drugs has fueled growing public and regulatory interest in peptides, most of the so-called “trendy” peptides still are not available by prescription, according to Tatem.
They may help with injury recovery, skin rejuvenation, sleep improvements and boosting of natural growth hormones, he said.
CLICK HERE TO SIGN UP FOR OUR HEALTH NEWSLETTER
“These were all medications that were designed to help people live well and live as healthy as possible,” the doctor told Fox News Digital. “And in reality, that was also their downfall in the American healthcare system, because if you are going to get a drug approved and to market, it has to treat a disease state.”
“These were all medications that were designed to help people live well and live as healthy as possible,” Tatem told Fox News Digital. (iStock)
Tatem confirmed that he’s seen a shift in patients confronting more than just baseline ailments, seeking advice on how to feel their best through new modes like testosterone therapy.
“The desire to function at our highest level is something that we all feel,” he said.
While nothing replaces the fundamentals — getting eight hours of sleep, eating a high-protein diet and maintaining a fitness routine that blends resistance training and cardio — Tatem said individualized treatments such as peptides may help support those healthy habits.
TEST YOURSELF WITH OUR LATEST LIFESTYLE QUIZ
“If you end up pulling a tendon or pulling a hamstring, and you’re just now starting to get some momentum in the gym, that’s really where peptides start to step in,” he added.
Experts advise consumers to avoid gray-market products, to work only with qualified physicians and reputable pharmacies, and to treat peptides as part of a broader health plan — not a shortcut or risk-free supplement.
Semaglutide (GLP-1) weight-loss drug Wegovy, made by pharmaceutical company Novo Nordisk, is designed to treat type 2 diabetes, but is widely known for its effect on weight loss. Picture date: Wednesday, October 16, 2024. (James Manning/PA Images via Getty Images)
In a statement shared with Fox News Digital, a Novo Nordisk spokesperson said the drugmaker is committed to working with regulators, law enforcement and “other key stakeholders” to ensure “affordable access to safe, effective and FDA-approved GLP-1 obesity medication like Wegovy and to protect patients from unapproved and untested knockoff drugs.”
“The desire to function at our highest level is something that we all feel.”
“Novo Nordisk supports FDA’s recent thorough scientific analysis and conclusion that there is no medical basis or clinical need for the continued mass compounding of unapproved semaglutide and liraglutide drugs,” they went on.
CLICK HERE TO DOWNLOAD THE FOX NEWS APP
“The agency’s decision reaffirms that compounding is meant to be a rare and limited exception to FDA’s gold-standard drug approval framework that ensures that medicines in the U.S. are safe and effective.”
Fox News Digital reached out to the FDA and Eli Lilly for comment.
-
Idaho5 minutes agoUnknown man stole dead teen’s identity 25 years ago to obtain $300K in government aid, Idaho jury finds
-
Illinois11 minutes agoPritzker is hopeful lawmakers will pass bill that could keep Bears in Illinois as deadline nears
-
Indiana17 minutes agoOfficer shot multiple times inside Indiana hospital ER
-
Iowa23 minutes agoSuper Bowl Winning Quarterback, Iowa Native Set Adds More To Resume
-
Kansas29 minutes agoPedestrian injured in Thursday crash in Kansas City later dies
-
Kentucky35 minutes agoSix Kentucky hospitals to receive portion of $105 million in FEMA funds
-
Louisiana41 minutes agoPortion of Louisiana Highway 1 to be named after fallen Vivian officer
-
Maine47 minutes agoMaine ballot initiative to prevent trans athletes in girls sports could be ruled invalid
