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A U.S. Food and Drug Administration advisory panel voted Tuesday to recommend emergency use of a smaller dose of Pfizer's coronavirus vaccine for children aged 5 to 11, advancing plans to offer the shots to 28 million young kids across the United States.

The vote was nearly unanimous at 17-0, with one abstention, and the FDA is expected to make a final ruling in a matter of days.

D...

Moderna announced Monday that its COVID-19 vaccine safely triggers a strong immune response in children aged 6 to 11.

Company data shows that a month after receiving both doses of the vaccine, children's antibody levels were 1.5 ...

A lower dose of Pfizer's coronavirus vaccine is 90.7% effective in preventing symptomatic COVID-19 in children aged 5 to 11, according to new clinical trial data from the company.

The data was given to the U.S. Food and Drug Administration on Friday, and the agency is expected to release its own analysis of the trial ...

The Pfizer-BioNTech vaccine booster restored close to full protection against COVID-19 in a late-stage trial involving 10,000 people, the company announced Thursday.

They said the booster was 95.6% effective and that they plan to submit the latest data to the U.S. Food and Drug Administration and regulators in other nations.

"These results provide further evidence of the benefits of...

Onions from Mexico have been linked to a salmonella outbreak that's sickened 652 people in 37 states, federal health officials said Wednesday.

So far, there have been 129 hospitalizations, but no deaths.

Investigators have traced one source of the outbreak to whole red, white and yellow onions that were imported from Chihuahua, Mexico, and distributed across the United States by Pro...

The White House on Wednesday unveiled a national plan to roll out coronavirus vaccines for 5- to 11-year-olds that is designed to make getting shots as easy and comfortable as possible for both kids and their parents.

Rather than mass vaccination sites, the Biden administration plans to have pediatric COVID shots delivered in settings that parents know and trust.

"Nationwide, more t...

Affordable over-the-counter hearing aids could soon bring relief to millions of Americans suffering from hearing loss, under a landmark proposal announced Tuesday by the U.S. Food and Drug Administration.

The proposal would create a category of hearing aids that could be sold directly to consumers, without either a medical exam or a fitting by an audiologist.

Until now, folks suffer...

In a unanimous vote, the U.S. Food and Drug Administration's vaccine advisory panel on Friday recommended that the agency grant emergency use of booster shots of Johnson & Johnson's coronavirus vaccine.

The FDA is expected to make a decision within days that will help guide the 15 million Americans who have received the Johnson & Johnson vaccine, many of whom have felt left out of the boo...

Mirroring a similar recommendation issued last month for the Pfizer COVID-19 vaccine, an expert advisory panel to the U.S. Food and Drug Administration on Thursday recommended a half-dose booster shot of the Moderna vaccine be given to certain recipients six months after their second shot.

Panelists recommended that everyone aged 65 or older who received the two-dose Moderna regimen get a...

Former U.S. Food and Drug Administration commissioner Robert Califf is under strong consideration by the White House to once again lead the agency.

The FDA hasn't had a permanent head for more than eight months and is being overseen by acting commissioner Janet Woodcock. Under federal law, President Joe Biden has until mid-November to pick a new FDA leader, but three people with inside kn...

In a development that could mean Johnson & Johnson might encounter resistance over its application for authorization of a booster shot of its coronavirus vaccine, a new analysis filed by the U.S. Food and Drug Administration on Wednesday suggests the company's evidence may not be strong enough for approval.

A key test used by the company to measure immune response from a booster shot six ...

The U.S. Food and Drug Administration announced Wednesday that it is lowering the recommended levels of sodium in processed, packaged and prepared foods.

The goal of the new, voluntary guideline is to help reduce Americans' average sodium intake from 3,400 milligrams (mg) to 3,000 mg per day — roughly a 12% reduction — over the next 2.5 years.

"It's really a pivotal day for the...

Maple Island Inc. announced Friday that it has recalled three lots of Parent's Choice Rice Baby Cereal because of elevated levels of arsenic in the products.

A sample from the three lots, which were sold only at Walmart, tested above the guidance for naturally occurring inorganic arsenic, according to a company announcement on the recall from Maple Island that was posted on the U.S. Food ...

Millions of Americans who got the Moderna and Johnson & Johnson coronavirus vaccines have had to watch those who received the Pfizer vaccine roll up their sleeves for a booster shot, wondering when they will get the same chance at extra protection.

This Thursday and Friday, an advisory panel to the U.S. Food and Drug Administration will tackle that pressing question.

The panel's del...

The U.S. Food and Drug Administration on Tuesday announced its first authorization of an electronic cigarette.

The permission to sell was granted to R.J. Reynolds for three of its Vuse tobacco-flavored vaping products.

"Today's authorizations are an important step toward ensuring all new tobacco products undergo the FDA's robust, scientific premarket evaluation. The manufacturer's d...

Pfizer Inc. announced Thursday that it has asked the U.S. Food and Drug Administration for emergency approval for its coronavirus vaccine to be given to children between the ages of 5 and 11.

"We're committed to working with the FDA with the ultimate goal of helping protect children against this serious public health threat," the company said in a

Medtronic has expanded a recall of its MiniMed 600 series insulin pumps to include more than 463,000 of the devices.

The pumps may deliver incorrect dosing of insulin and the recall has been identified by the U.S. Food and Drug Administration as a Class I recall -- the most serious type -- because use of the recalled devices may cause serious harm or death.

The pumps are used by peo...

Pharmaceutical giant Merck & Co. said Friday that it will seek federal approval for emergency use of its new antiviral pill molnupiravir, after a clinical trial showed the drug halved the risk of hospitalization or death when given to high-risk people shortly after infection with COVID-19.

The new medication is just one of several antiviral pills now being tested in studies, and experts s...

It turns out that the pandemic has reaped one unexpected benefit: As teens were kept home more often, their use of electronic cigarettes dropped by nearly 40%, a new report finds.

U.S. health officials said these numbers should be taken with a grain of salt, but the decrease in vaping in 2021 is probably real and makes sense because teens often vape socially, one expert told the Asso...

Despite the troubling findings of a congressional report released earlier this year on toxins in baby foods, a new report finds even more manufacturers are selling baby foods that contain potentially unsafe levels of heavy metals.

The toxins in question include dangerous levels of arsenic, lead, cadmium and mercury, among others.

"No level of toxic heavy metals and exposure to them ...

A specimen cup full of bloody urine.

Decaying feet that sport blackened, rotting toes -- some already amputated.

A pale boy with dark circles under his eyes, drawing breath through an oxygen mask.

Around 179,000 deaths in the United States might have been prevented over the past decade if smokers had been forced to confront such images every time they reached for a pack of cig...

The U.S. Food and Drug Administration on Wednesday approved Pfizer booster shots for people over 65 and for those at high risk of severe COVID-19.

Under the emergency use authorization, the booster shots should be given at least six months after a person is fully vaccinated.

Wednesday's move is likely the beginning of a staggered campaign to deliver booster shots to all Americans, s...

An advisory panel to the U.S. Centers for Disease Control and Prevention will meet on Wednesday to discuss which Americans, if any, should get Pfizer booster shots to rev up their immunity to COVID-19.

Their recommendation will follow a decision by a U.S. Food and Drug Administration expert panel to only give booster shots to those over 65 and those in high-risk groups.

The CDC pane...

Millions of U.S. sleep apnea patients are scrambling to find ways to protect their nightly slumber, following a voluntary recall from one of the nation's leading manufacturers of CPAP breathing machines.

Philips Respironics agreed to a voluntary recall of continuous positive airway pressure (CPAP) machines in late June, over concerns that noise-dampening foam inside the devices might degr...

An advisory panel to the U.S. Food and Drug Administration on Friday recommended a third Pfizer-BioNTech COVID vaccine booster shot for all Americans aged 65 or older, as well as for those deemed to be at high risk for severe illness.

According to The New York Times, that vote came after a near unanimous decision (16 to 2) by the same independent panel of experts that said no to ...

Pfizer is expanding the recall of its anti-smoking drug Chantix (varenicline), the company announced Friday.

The nationwide recall of all Chantix 0.5 mg and 1 mg tablets was prompted because they may contain levels of a nitrosamine, N-nitroso-varenicline, that are at or above levels approved by the U.S. Food and Drug Administration.

Long-term ingestion of N-nitroso-varenicline may b...

U.S. Food and Drug Administration advisors will meet Friday to consider whether it is safe and effective for Americans to receive a third "booster" dose of the Pfizer-BioNTech COVID-19 vaccine.

The FDA posted the materials it intends to use in the review on Wednesday. The advisory panel will review a variety of evidence, including new data from Israel, the Associated Press repo...

Many parents hoping for COVID-19 vaccines for their children younger than 12 may get their wish this fall, according to Dr. Anthony Fauci.

The vaccines could be authorized by the U.S. Food and Drug Administration this fall for children ages 5 to 11, Fauci told CNN on Tuesday.

"If you look at the studies that we at the (National Institutes of Health) are doing in collaborati...

TUESDAY, Sept. 14, 2021 (HealthDay News) -- New data out of Israel, to be published this week, could bolster the notion that a third booster shot of the COVID-19 vaccine significantly lowers a recipient's odds for severe illness.

The data is scheduled to be published in the peer-reviewed New England Journal of Medicine, ahead of this week's U.S. Food and Drug Administration advi...

U.S. approval of the Alzheimer's drug Aduhelm is already mired in controversy. Now a new study finds that most Alzheimer's patients could not have taken part in clinical trials that led to the green light.

In June, the U.S. Food and Drug Administration gave accelerated approval to Aduhelm (aducanumab) for treating patients with mild cognitive impairment or mild dementia from Alzheimer's d...

COVID-19 vaccine booster shots might not be needed for most people, according to a large international review.

The review -- conducted by a team that included scientists from the World Health Organization and the U.S. Food and Drug Administration -- concluded that current vaccines are effective enough against severe COVID-19, even from the Delta variant, and that booster shots are unnece...

The U.S. Food and Drug Administration on Thursday announced that it had rejected the applications of nearly a million electronic cigarettes and related products.

But it also delayed a decision on the fate of the leading vape product brand, Juul, drawing an outcry from anti-vaping groups.

Juul products will remain on the market for now, more than 10 years after e-cigarettes first ...

Until now, folks suffering from hearing loss typically have had to fork out thousands of dollars for a device that could be adjusted only by a professional audiologist.

No wonder that only one-quarter of the nearly 29 million U.S. adults who could benefit from a hearing aid have actually tried one, according to the U.S.

  • Dennis Thompson HealthDay Reporter
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  • September 9, 2021
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  • An alliance of leading U.S. cancer centers has updated guidance about COVID-19 vaccine boosters for cancer patients and the people around them.

    The National Comprehensive Cancer Network's new recommendations are intended for health care providers.

    "COVID-19 can be very dangerous, especially for people living with cancer, which is why we're so grateful for safe and effective vaccines...

    Top U.S. health officials have reportedly warned the White House to curtail its plans to offer COVID-19 booster shots to Americans later this month.

    Leaders of the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention both told White House pandemic coordinator Jeffrey Zients in a meeting Tuesday that their agencies will not be able to fully assess the n...

    Two senior leaders in the U.S. Food and Drug Administration's vaccine review office are stepping down, but their departures won't slow efforts to combat the pandemic, the agency said Tuesday.

    "We are confident in the expertise and ability of our staff to continue our critical public health work, including evaluating COVID-19 vaccines," FDA spokesperson Stephanie Caccomo told CNN....

    Despite studies showing that it doesn't work against COVID-19, prescriptions for the anti-parasite drug ivermectin have climbed sharply in recent weeks as COVID-19 cases surge nationwide, the U.S. Centers for Disease Control and Prevention says.

    Prescriptions for what was originally a drug for animals soared to more than 88,000 a week in mid-August from a pre-pandemic average of 3,600 per...

    Treatment with two monoclonal antibodies lowers the odds of hospitalization for high-risk COVID-19 patients with mild to moderate illness, according to a new study.

    "Our conclusion overall at this point is that monoclonal antibodies are an important option in treatment to reduce the impact of COVID-19 in high-risk patients," said senior author Dr. Raymund Razonable, an infectious diseases...

    A first-of-a-kind nerve stimulation treatment for people who have problems moving their arms after a stroke has been approved by the U.S. Food and Drug Administration.

    "People who have lost mobility in their hands and arms due to ischemic stroke are often limited in their treatment options for regaining motor function," explained Dr. Christopher Loftus. He is acting director of the FDA's ...

    Three small e-cigarette makers have been told by the U.S. Food and Drug Administration to stop selling their flavored products.

    The orders issued Thursday to JD Nova Group LLC, Great American Vapes and VaporSalon require them to remove 55,000 existing or planned flavored products from the market or risk enforcement, the Washington Post reported.

    In the FDA's first marketing...

    A new pill specifically designed to prevent migraines appears to do the job, a new clinical trial finds.

    Atogepant cut patients' migraine days in half over 12 weeks of treatment, without causing serious side effects, the researchers said.

    Experts said the drug, if approved by the U.S. Food and Drug Administration, would give migraine sufferers a welcome new option.

    "There's a ...

    A recall of more than a dozen types of Philips breathing machines because of potential cancer risks has millions of Americans struggling to find replacements to deal with sleep disorders, breathing problems and respiratory emergencies.

    The recall involves certain Respironics BiPAP (bi-level positive air pressure), CPAP (continuous positive air pressure) and ventilator machines made before...

    The U.S. Food and Drug Administration said Tuesday that it has sent a warning letter to a pet food company linked to contaminated food that may have caused illness or death in hundreds of dogs.

    The letter was issued after inspections of Midwestern Pet Foods Inc.'s manufacturing sites found violations of the Federal Food, Drug and Cosmetic Act, the agency said in a

  • Robert Preidt and Ernie Mundell and Robin Foster
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  • August 18, 2021
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  • Avanti Frozen Foods has expanded its recall of various frozen cooked, peeled and deveined shrimp products that may be contaminated with salmonella.

    The more than two dozen products were sold under various brand names and distributed across the United States between November 2020 and May 2021, the

  • Robert Preidt and Robin Foster
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  • August 17, 2021
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  • The drug Xywav has been approved for expanded use in adults with a rare sleep disorder called idiopathic hypersomnia, the U.S. Food and Drug Administration said Thursday.

    The drug has a checkered history: In the 1960s, it was given to women during childbirth to dampen their consciousness, The New York Times reported, while an illicit version made headlines as a "date rape" drug i...

    Since 2008, anti-seizure drugs have carried a warning that they may increase users' suicide risk. But a new analysis finds no evidence of such a risk with newer medications.

    Researchers found that five medications approved since 2008 showed no link to suicide risk among patients who participated in clinical trials of the drugs.

    The findings, they said, argue against the "blanket" wa...

    An outside advisor to the U.S. Food and Drug Administration's review of the controversial Alzheimer's drug Aduhelm is now speaking out, arguing that the approval was based on dodgy science and involved questionable collaboration between regulators and the drug's maker.

    "I'm not surprised at the controversy because I think it's a horrible decision. I think the FDA got it wrong," said Dr. G...

    Accidental exposure to fentanyl pain patches is putting children's lives at risk, the U.S. Food and Drug Administration warns.

    Fentanyl is a powerful opioid pain reliever; so powerful that fentanyl patches are typically only prescribed to patients who require round-the-clock, long-term pain relief, such as cancer patients. They're generally replaced every three days.

    Kids can overdo...

    The controversial new Alzheimer's drug Aduhelm is creating something of a civil war in medicine, as health networks, hospitals, insurers and individual doctors weigh impending discussions with patients about whether they should take the medication.

    Many doctors believe the U.S. Food and Drug Administration "moved the goalposts" to approve Aduhelm (aducanumab) in early June, and they aren'...

    As he urged Americans who are still hesitant to get vaccinated, President Joe Biden told an Ohio town hall on Wednesday night that he expected the U.S. Food and Drug Administration would soon give final approval to COVID-19 vaccines.

    At the moment, all three vaccines being used in this country have only emergency use approval. But many medical professionals have pushed for the final ...