Tag: fda

FDA Grants Speedy Approval to Eli Lilly’s Weight-Loss Pill for Obesity

Federal regulators on Wednesday approved Eli Lilly’s new weight-loss pill, a second daily oral medication to treat obesity and other weight-related conditions.

The Food and Drug Administration granted expedited approval to orforglipron, a GLP-1 drug that works like widely used injectable medications to mimic a natural hormone that controls appetite and feelings of fullness.

The drug, which will be branded as Foundayo, is expected to begin shipping Monday. The company said people with insurance may be able to get the drug starting at $25 per month with a Lilly discount card. Prices for people paying cash will range between $149 per month to $349 per month, depending on the dose.

The new pill joins drugmaker Novo Nordisk’s oral Wegovy pill, which has spurred more than 600,000 prescriptions in the United States since it was approved in December.

The FDA authorized Eli Lilly’s drug as part of a new program aimed at cutting drug approval times. The agency said it reviewed the company’s application in 50 days.

In a clinical trial of more than 3,000 adults with obesity, participants who received the highest dose of orforglipron, 36 milligrams, lost 11.2% of their body weight — about 25 pounds on average — over more than 16 months. That compared with a 2.1% weight loss, or less than 5 pounds, in patients who received a placebo, or dummy pill, according to the New England Journal of Medicine.

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FDA Warns of Deaths Linked to Drug It Wants Removed From Market

The Food and Drug Administration said in a March 31 alert that it has learned of eight deaths linked to a drug called avacopan that is used to treat blood vessel inflammation.

A review of studies, documents from avacopan manufacturer Amgen, and reports to the FDA’s adverse event reporting system resulted in the identification of 76 cases of drug-induced liver injury “with reasonable evidence of a causal association with avacopan use,” the FDA said in a drug safety alert.

Fifty-four of the cases led to hospitalization, and eight ended in death.

Some of the cases involved a syndrome that features the destruction of bile ducts in the liver, which can lead to permanent liver damage.

“Patients should contact their health care professional immediately if they develop any signs or symptoms that may indicate liver injury, such as: feeling more tired than usual; nausea; vomiting; unusual itching; light-colored stools; yellowing of skin or eyes; dark urine; swelling in the stomach or abdomen; or pain in the right upper abdomen,” the FDA stated. “Patients should talk to their health care professional about the safety risks associated with Tavneos and whether to continue therapy or switch to alternative treatments.”

Avacopan, also known as Tavneos, was approved by the FDA in 2021 for the treatment of severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis, or blood vessel inflammation.

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FDA Recalls Aphrodisiac Chocolates Containing Viagra Ingredients

The U.S. Food and Drug Administration has issued a recall for two chocolate products sold by a California adult novelty store, Gold Lion Aphrodisiac Chocolate and ilum Male Sexual Enhancement Chocolate, after discovering they contain high levels of the active ingredients found in prescription medications like Viagra and Cialis. Consuming these chocolates could lead to a life-threatening drop in blood pressure, especially for men with heart conditions who take nitrates.

Why it matters

The recall highlights the risks of purchasing unregulated sexual enhancement products that may contain undisclosed and potentially harmful pharmaceutical ingredients. Consumers should be wary of any over-the-counter products making claims about improving sexual performance, as they may contain dangerous adulterants.

The details

According to the FDA, the recalled chocolates were found to contain sildenafil, the active ingredient in Viagra, and tadalafil, the active ingredient in Cialis. These prescription drug components can interact dangerously with nitrates, potentially causing a severe and sudden drop in blood pressure that could be life-threatening. The chocolates were sold by Gear Isle, an adult novelty store in California, under the names Gold Lion Aphrodisiac Chocolate and ilum Male Sexual Enhancement Chocolate.

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FDA Launches New AI-Powered System to Track Drug and Vaccine Side Effects

For decades, the system designed to catch dangerous side effects from drugs, vaccines, and consumer products has been failing. Not because the problems weren’t happening — but because the infrastructure meant to track them was too fragmented, too slow, and too burdensome to keep up.

The result was a growing gap between what patients experienced and what showed up in federal safety records. Patterns of harm went undetected or took far too long to surface, and the public was left making health decisions based on an incomplete picture.

Now the U.S. Food and Drug Administration (FDA) is attempting to close that gap with a sweeping technology overhaul — one that could fundamentally change how quickly you see safety signals and how much control you have over your own health choices. Here’s what the new system does, what it replaces, and why it matters.

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Moderna threatens American jobs after FDA snubs mRNA flu shot, trial looked ‘scientifically lax’

For years before he became director of the Food and Drug Administration’s Center for Biologics Evaluation and Research, epidemiologist Vinay Prasad openly railed against what he perceived as the shoddy design of drug trials and the deference regulators gave them, sending biotech stocks tumbling when Commissioner Marty Makary appointed him.

A vaccine maker that hit the federal jackpot during COVID-19 acted caught off-guard when the former University of California San Francisco medical professor put his gripes into practice, halting its FDA application for a new mRNA flu vaccine based on what he considered weak trial design.

Moderna accused Prasad, who described his predecessor Peter Marks as a “bobblehead” for drug approval, of changing the rules in the middle of the game by refusing to review its biologics license application (BLA) without citing “specific safety or efficacy concerns.”

Prasad’s Feb. 3 “refusal to file” letter – which Moderna posted a week later on its COVID resources page for some reason – says the FDA warned the company before it even started the mRNA flu trial that the proposed design raised red flags.

“CBER does not consider the application to contain a trial ‘adequate and well-controlled’ and the application is therefore, on its’ [sic] face, inadequate for review,” because the control arm “does not reflect the best-available standard of care in the United States at the time of the study,” Prasad said, which was “consistent with FDA’s advice” before the study.

This was just the agency’s “preliminary review of the application and is not indicative of deficiencies that would be identified later,” when the FDA conducts a “substantive review,” Prasad emphasized, implying fresh hurdles for Moderna even if it runs a new trial.

Moderna CEO Stéphane Bancel responded with his own thinly veiled threat against Prasad, who had already left the administration once under assault from populist and corporate conservatives who blasted his avowed support for progressive policies and more regulation before Prasad joined the administration. 

CBER’s decision, which Bancel reiterated “did not identify any safety or efficacy concerns with our product, does not further our shared goal of enhancing America’s leadership in developing innovative medicines,” said the billionaire Frenchman, who came to Boston-based Moderna from French diagnostics company BioMerieux.

“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,” Bancel said, hinting the company would take jobs overseas if the FDA continued its current trajectory.

Department of Health and Human Services spokesperson Andrew Nixon told Just the News Moderna ignored “very clear FDA guidance from 2024 to test its product in a clinical trial against a CDC-recommended flu vaccine to compare safety and efficacy.”

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FDA Requires Vaccine Makers to Include Febrile Seizure Warning on Flu Shot Labels

The U.S. Food and Drug Administration (FDA) notified six influenza vaccine manufacturers on Jan. 9, 2026 that they must add a warning about the risk of febrile (fever) seizures to their product information labels, citing newly identified postmarketing safety data. The notices, issued under the FDA’s statutory authority to mandate safety labeling changes, were sent to Sanofi, AstraZeneca, GlaxoSmithKline (GSK), and CSL Seqirus.1

According to the FDA, observational analyses conducted during the 2023–2024 and 2024–2025 influenza seasons identified a statistically significant increase in seizures caused by fevers occurring within one day of vaccination among children aged six months through four years, prompting the agency to conclude the findings constitute “new safety information” requiring disclosure in product labeling. In its notification letter, the FDA stated that the results of the analyses “suggest a causal relationship”—language the agency typically avoids unless compelled by evidence.2

The data suggested an “estimated attributable risk of 21.2 excess febrile seizure episodes per million standard-dose quadrivalent influenza vaccinations” and “an attributable risk of 44.2 excess febrile seizure episodes per million standard doses of trivalent [influenza] vaccinations.”

Risk of Febrile Seizures May Increase After Childhood Vaccinations

The Mayo Clinic website states that in some infants and young children fevers can cause convulsions (seizures). Doctors generally describe “simple” febrile seizures as associated with fevers over 100 F, short-lived and typically harmless, although “complex” febrile seizures can last longer than 15 minutes and occur more than once in a 24-hour period.3

It has been acknowledged in the medical literature that convulsions can include an increased risk of future epilepsy (uncontrolled seizure disorder).4 5 Febrile seizures have also been associated with a spectrum of brain dysfunction and rarely, severe brain injury or death.6 7

Bioengineer Brian Hooker, PhD said he disagrees with febrile seizures being characterized as harmless. He said:

Any seizure is bad, period. Mild’ febrile seizures can double a child’s chance of an epilepsy diagnosis and ‘complex’ febrile seizures—lasting more than 15 minutes —can increase that risk up to 10 times.8

On the topic of febrile seizures and childhood vaccines, Mayo Clinic states:

The risk of febrile seizures may increase after some childhood vaccinations. These include the diphtheria, tetanus and pertussis vaccine and the measles-mumps-rubella vaccine. A child can develop a low-grade fever after a vaccination. The fever, not the vaccine, causes the seizure.9

The U.S. Centers for Disease Control and Prevention (CDC) acknowledges that some vaccines are associated with a higher risk of febrile seizures than others, particularly in infants and young children, and that the risk increases when certain vaccines—such as the influenza, pneumococcal (PCV13), and DTaP vaccines—are administered during the same visit.

The agency also notes that measles-containing vaccines, especially the MMRV (measles, mumps, rubella, and varicella) combination, are associated with a higher risk of febrile seizures than their single-component counterparts, and that these events tend to occur within specific post-vaccination time windows. Still, CDC guidance emphasizes that the overall risk is small, that febrile seizures are typically short-lived and without lasting harm, and that vaccination should continue according to the recommended schedule.10

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Powdered whole milk may be culprit in botulism outbreak that sickened dozens of babies

Powdered whole milk used to make ByHeart infant formula could be the source of contamination that led to an outbreak of botulism that sickened dozens of babies.

The Centers for Disease Control and Prevention (CDC) reported the details on Friday.

Powdered whole milk may be culprit in botulism outbreak

What we know:

Testing by the U.S. Food and Drug Administration (FDA) found that bacteria in an unopened can of formula matched a sample from a sick baby — and it also matched contamination detected in samples of organic whole milk powder used to make ByHeart formula and collected and tested by the company, officials said. 

FDA testing also found contamination in a sample of whole milk powder supplied to ByHeart — and it matched the germ in a finished sample of the company’s formula.

What they’re saying:

A ByHeart official said the finding helps shed light on what has become a “watershed moment” for the company.

“We are focused on the root cause and our responsibility to act on what we’ve learned to help create a safer future for ByHeart and infant formula,” said Dr. Devon Kuehn, ByHeart’s chief scientific and medical officer.

What we don’t know:

While these results advance the agency’s understanding of the outbreak, the FDA said the findings are not conclusive, and the investigation continues “to determine the source of the contamination.”

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FDA Removes Web Content Saying Cellphones Are Harmless – HHS Launches Study

Without fanfare, the Food and Drug Administration has deleted multiple web pages asserting that cellphones are not dangerous. First reported by the Wall Street Journal, the move comes as the Department of Health and Human Services has begun a new investigation into potential health effects of cellphone radiation.

HHS Secretary Robert F. Kennedy Jr has previously declared that cellphones are causing harms that are not yet fully acknowledged. “There’s cellphone tumors. I’m representing hundreds of people who have cellphone tumors behind the ear. It’s always on the ear that you favor with your cellphone…We have the science,” Kennedy said in a 2023 appearance on the Joe Rogan Experience. “You should never put one next to your head… I put it on speakerphone or use earphones.” 

Responding to a Journal inquiry about the change to the FDA website, HHS spokesman Andrew Nixon said, “The FDA removed webpages with old conclusions about cellphone radiation while HHS undertakes a study on electromagnetic radiation and health research to identify gaps in knowledge, including on new technologies, to ensure safety and efficacy.” 

One of the deleted pages included a passage declaring that “the weight of scientific evidence has not linked exposure to radio frequency energy from cellphone use with any health problems.” There may be more scrubbing of the site to come: The Journal notes that the FDA’s site still has summaries of the deleted pages, but the links redirect to other generalized content about the agency’s regulatory mission. 

Kennedy, who had a career as an environmental litigator, has long engaged on this issue. Kennedy represented people suing phone companies for allegedly causing brain tumors, and won a 2020 case that compelled the Federal Communications Commission to reassess its wireless-radiation regulations. He was also chairman of Children’s Health Defense, which has been involved in litigation over 5G technology, and a case blaming an Idaho man’s cardiac issues on a cellphone tower. He has also pointed to radiation as a prime suspect in the mystery of widespread chronic illnesses among America’s children, “Our children are swimming around in a toxic soup, the Wi-Fi radiation is a lot worse than people think it is…yeah, from your cellphone,” Kennedy told Rogan in 2023.  

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FDA Commissioner CONFIRMS Agency Lied About DIETARY FAT for Decades to Benefit Big Pharma Interests — Says Low-Fat Advice Drove Americans to Eat More SUGAR and Suffer Higher HEART ATTACK Rates

Food and Drug Administration (FDA) Commissioner Dr. Marty Makary admitted that for nearly 20 years, the agency’s dietary guidance on fat was not just wrong, it was misleading, triggering a cascade of unhealthy eating habits that have devastated American health.

Speaking at a White House briefing on Wednesday alongside HHS Secretary Robert F. Kennedy Jr., Makary unleashed a scathing indictment of the “medical dogma” that has governed American kitchens since the 1980s.

The Commissioner revealed that the government’s crusade against saturated fats, meat, butter, and eggs, was not only scientifically hollow but directly responsible for the explosion of the chronic disease epidemic.

“For decades, we’ve been fed a corrupt food pyramid that has had a myopic focus on demonizing natural healthy saturated fats, telling you not to eat eggs and steak, and ignoring a giant blind spot: refined carbohydrates, added sugars, ultra-processed food,” said Makary.

“Ironically, they took out the healthy, saturated fat and added sugar, and that was supposed to be healthier. We now have a chronic disease epidemic. The focus on fat has paralleled and ushered in an entire generation of kids with high insulin resistance and levels of inflammation never seen before in the human race.”

On Thursday, Makary doubled down on this new finding, criticizing the long-standing “low-fat” dogma that had led Americans to load up on sugar while avoiding healthy fats.

He suggested the narrative was kept alive, at least in part, to shield powerful corporate interests—including Big Pharma.

Most damning, Makary cited data showing that people who followed low-fat diets actually suffered higher rates of heart attacks than those who consumed healthy fats, directly contradicting decades of so-called “expert” federal nutrition advice.

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FDA Leadership Refuses to Add Black Box Warning to mRNA Injections—Despite FDA Scientists Recommending It

A few days ago, CNN reported that the FDA intended to place a black box warning on COVID-19 mRNA injections for serious adverse events, including death.

However, in a striking reversal first reported by Maryanne Demasi, FDA Commissioner Dr. Marty Makary appeared on Bloomberg and claimed the agency now has “no plans” to implement a black box warning—despite the FDA’s own Center for Safety and Epidemiology formally recommending one. He claimed that Dr. Vinay Prasad and “leadership” thought it would be a bad idea.

Dr. Makary stated:

Now, when it comes to the black box warning, we have no plans to put that on the COVID vaccine. The Safety and Epidemiology center within the FDA did recommend that it was a recommendation formally put out. But some of our scientists and leadership, like Dr. Vinay Prasad, have said it may be different today than it was in the first year of COVID when the shot came out.

Because when you have those two doses three months apart, that’s when you see the side effects go way up, like myocarditis in young people. Now that it’s annual, you may not see that same prevalence.

So we don’t want to extrapolate findings to today if it’s not transferable.

This rationale is deeply flawed—and gravely worrisome. It assumes that cardiotoxic injury from mRNA injections is acute, transient, and dose-interval dependent, rather than structural, cumulative, and capable of causing delayed fatal outcomes. That assumption is directly contradicted by the peer-reviewed literature.

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