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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 sa...

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<...

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 Administra...

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 ...

    Possible listeria contamination has triggered the nationwide recall of more than two dozen muffin products made by Give and Go Prepared Foods, the U.S. Food and Drug Administration said Wednesday.

    The recalled products were sold across the country and include a variety of Uncle Wally's twin muffins, The Worthy Crumb large muffins, Stop n Shop mini muffins, 7-Eleven Selects muffins, Freshn...

    Pfizer Inc. announced on Friday that the U.S. Food and Drug Administration has granted priority review to its COVID-19 vaccine, positioning the vaccine for full approval by January.

    The Pfizer vaccine has been administered to more Americans than any other shot so far in the U.S. vaccination campaign. According to data from the U.S. Centers for Disease Control and Prevention, some 85 milli...

    The first full approval of a drug to treat lymphoma in dogs has been granted by the U.S. Food and Drug Administration.

    "While canine lymphoma affects fewer than 70,000 dogs in the U.S. annually, it accounts for up to 24% of all cancers in dogs, making it one of the most significant canine cancers," Steven Solomon, director of the FDA's Center for Veterinary Medicine, said in an agency new...

    Two major U.S. health systems say they will not administer the controversial new Alzheimer's drug Aduhelm.

    The decisions by the Cleveland Clinic and Mount Sinai's Health System in New York City are the latest fallout from the U.S. Food and Drug Administration's widely criticized approval of the Biogen drug on June 7, The New York Times reported.

    Many experts say there's no ...

    Five Neutrogena and Aveeno spray sunscreen products have been recalled because they may contain small amounts of benzene, Johnson & Johnson announced Wednesday.

    Benzene is a human carcinogen and can get into the body through the skin, through the mouth and by inhalation, the company said in a statement.

    "Out of an abundance of caution, we are recalling all lots of these specific aer...

    The U.S. Food and Drug Administration on Thursday issued new prescribing rules for the controversial Alzheimer's medication Aduhelm that will likely limit its use.

    When first approved a month ago, the FDA said Biogen's monthly IV drug was for all Alzheimer's patients. The agency now says the drug is appropriate for patients with early or mild Alzheimer's but that it has not been studied i...

    THURSDAY, July 1, 2021 (Healthday News) -- The U.S. Food and Drug Administration's controversial approval of a new Alzheimer's drug, along with its high price, is now being investigated by two House committees.

    "We have serious concerns about the steep price of Biogen's new Alzheimer's drug Aduhelm and the process that led to its approval despite questions about the drug's clinical benefi...

    When choosing and using flea and tick products for your pets, there are a number of things to consider, the U.S. Food and Drug Administration says.

    Work with your veterinarian to select the right product for your pet's species, life stage and weight.

    These products range from pills and chews given by mouth to collars, sprays, dips, shampoos, powders, and "spot-ons," liquid products ...

    The coronavirus pandemic has had an unexpected side effect -- a wave of bad reactions to alcohol-based hand sanitizers.

    Vapors from the products can cause headache, nausea and dizziness, according to the U.S. Food and Drug Administration, which advises consumers to use the products in well-ventilated areas.

    "We have received increasing reports of these side effects since the start ...

    Antibody treatments are safe and effective for transplant patients with mild to moderate COVID-19, a new study shows.

    Monoclonal antibodies help prevent the SARS-CoV-2 virus from attaching to cells, which helps block the spread of infection.

    The findings are important, researchers said, because transplant patients with COVID are more likely to be severely ill or die.

    "Monoclon...

    The U.S. Food and Drug Administration has approved the first new drug to treat Alzheimer's disease in nearly two decades, in a controversial decision that left the agency defending its reputation and its science.

    Aduhelm (aducanumab) treats Alzheimer's by clearing out amyloid beta, a sticky protein known to form plaques in the brains of early-stage patients.

    It is the first approved...

    The first drug ever shown to slow the progression of Alzheimer's disease could be approved by the U.S. Food and Drug Administration on Monday, but experts say that approval will be surrounded by controversy.

    In clinical trials, aducanumab showed a 22% reduction in the development of thinking and memory problems associated with Alzheimer's disease, according to a statement from the Alzheim...

    It has been an elusive goal so far -- finding a potent treatment that can beat back the new coronavirus before it grabs a hold of a patient's immune system and sends it into overdrive.

    But new research suggests that more than a dozen existing drugs or drugs under development may do the trick.

    Investigators tested more than 12,000 drugs in two different types of human cells infected ...

    Moderna plus Pfizer? J&J plus Moderna? There's a new clinical trial underway to assess the safety and effectiveness of mixing different types of booster shots in adults who have been fully vaccinated against COVID-19.

    "Although the vaccines currently authorized by the U.S. Food and Drug Administration offer strong protection against COVID-19, we need to prepare for the possibility of ne...

    Women who are struggling to get pregnant, beware of false dietary supplements that claim to help cure infertility and other reproductive health issues.

    Such supplements are not approved by the U.S. Food and Drug Administration and they could prevent patients from seeking effective, approved drugs, the agency warned.

    "These purported fertility aids seek to profit off of the vulnerabi...

    A third antibody treatment designed to keep high-risk COVID-19 patients from winding up in the hospital was approved for emergency use by the U.S. Food and Drug Administration on Wednesday.

    Importantly, in lab tests the newly authorized drug, dubbed sotrovimab, neutralized the highly infectious virus variant that is crippling India, as well as variants first spotted in Britain, South...

    The U.S. government and nonprofits are replacing drug companies as the main drivers of Alzheimer's disease research, two new studies show.

    The findings are from an analysis of national data by Jeffrey Cummings, a research professor at the University of Nevada, Las Vegas School of Integrated Health Sciences.

    In one study, his team found that the number of Alzheimer's clinical trials ...

    The U.S. Food and Drug Administration is warning that strong magnets in some cellphones and smartwatches can interfere with pacemakers and other implanted medical devices.

    Studies have shown that these high-strength magnets may cause some implants to switch to "magnet mode," stopping normal functioning until the magnet is moved away from the device.

    Many implants have a "magnet mode...

    You're getting no real benefit from taking weight-loss supplements like garcinia cambogia, green tea extract, glucomannan, conjugated linoleic acid or chitosan, two new reviews show.

    Most of the clinical trials studied didn't show these supplements producing any weight loss among users, the researchers said. In the rare cases where people did lose weight, they didn't drop enough pounds to...

    People may think they know what 'Best before' food date labels mean, but a new study reveals that many consumers misunderstand them.

    The study of over 2,600 U.S. adults "showed that an overwhelming majority of consumers say that they use food date labels to make decisions about food and say they know what the labels mean," said study author Catherine Turvey,. She's from the department of ...

    The U.S. Food and Drug Administration on Thursday proposed a ban on menthol cigarettes, a move that the agency has tried before and one that public health experts and civil rights groups have pushed for years.

    Menthol cigarettes have been marketed aggressively to Black Americans for decades: About 85% of Black smokers use menthol brands, the FDA said, and research shows menthol cigarettes...