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FDA Panel OKs Pfizer Booster Shot for  People 65 or Older, But Not Younger

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 Recalls All Lots of Anti-Smoking Drug Chantix Due to Potential Carcinogen

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...

FDA Advisory Panel to Meet on COVID Booster Shots

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<...

COVID Vaccines for Kids Under 12 Could Come This Fall: Fauci

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...

Israeli Data on COVID Boosters to Be Published This Week in Major Journal

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...

Most Alzheimer's Patients Wouldn't Have Qualified for Controversial Drug's Trial: Study

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...

Data Doesn't Support Need for COVID-19 Vaccine Boosters: Experts

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...

FDA Bans Sale of Nearly a Million E-Cigarettes; Allows Juul to Remain on Market

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 ...

Could Cheaper, Over-the-Counter Hearing Aids Finally Be Here?

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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  • Which Cancer Patients Need a COVID Booster Shot Most?

    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 Federal Health Officials Ask White House to Scale Back on COVID Boosters

    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 Top Officials in FDA's Vaccine Review Office to Retire

    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....

    Prescriptions Rise for Veterinary Drug for COVID Patients, Even Though It Won't Help

    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...

    Monoclonal Antibody Combo Keeps High-Risk COVID Patients Out of Hospital

    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...

    FDA Approves First Nerve-Stimulation Device to Aid Stroke Recovery

    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 ...

    FDA Tells Three Small E-Cigarette Makers to Stop Selling Flavored Products

    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...

    Experimental Drug Could Cut Migraine Frequency

    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 ...

    Recall of Philips Breathing Machines Affects Millions of Americans

    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...

    Illness, Death in Hundreds of Dogs Spurs FDA Action Against Dog Food Maker

    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 Expands Recall of Frozen Shrimp for Possible Salmonella Contamination

    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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  • 'Date Rape' Drug Gets FDA Approval to Treat Rare Sleep Disorder

    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...

    Time to Rethink Suicide Warnings on Labels for Anti-Seizure Meds?

    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...

    FDA Panel Advisor Who Panned New Alzheimer's Drug Speaks Out

    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...

    Kids Still Dying From Accidental Exposure to Fentanyl Pain Patches

    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...

    Doctors Divided Over Use of Controversial New Alzheimer's Drug

    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'...

    Biden Says Full Approval for COVID Vaccines Coming Soon

    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 ...

    Muffins Recalled for Possible Listeria Contamination

    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...

    FDA to Prioritize Full Approval for Pfizer COVID Vaccine

    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...

    FDA Approves First Lymphoma Drug for Dogs

    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 Health Systems Won't Administer Controversial New Alzheimer's Drug

    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 Sunscreens Recalled Due to Benzene

    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...

    New Prescribing Instructions Tighten Use of Controversial Alzheimer's Drug

    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...

    House Committees to Investigate New Alzheimer's Drug Approval

    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...

    How to Safely Use the Right Flea and Tick Product for Your Pet

    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 ...

    Hand Sanitizer Vapors Can Cause Nausea, Dizziness

    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 ...

    COVID Antibody Treatment Is Safe, Effective in Transplant Patients

    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...

    FDA Defends Approval of Controversial Alzheimer's Drug

    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...

    'Historic' Decision Expected on U.S. Approval of Alzheimer's Drug

    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...

    Many Existing Drugs Could Be Potent COVID Fighters: Study

    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 ...

    NIH Starts Trial Assessing 'Mix & Match' COVID Vaccine Approach

    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...

    FDA Warns of Bogus Fertility Claims for Some Supplements

    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...

    FDA Approves Third COVID Antibody Treatment for Emergency Use

    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...

    There's Been a Shift in Who's Funding Alzheimer's Research

    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 ...

    Magnets in Cellphones, Smartwatches Might Affect Pacemakers, FDA Warns

    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...

    Reviews Find No Evidence Weight-Loss Supplements Work

    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...

    Many Consumers Misunderstand Those 'Best Before' Food Labels

    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 ...

    FDA Poised to Ban Menthol Cigarettes

    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...

    Race Against Time: Stricken With ALS, She's Seeking Access to Experimental Drug

    Like many proud moms, Lisa Stockman-Mauriello of Summit, N.J., is looking forward to exciting milestones in lives of her three sons over the coming months: One will graduate college, one will enter college, and the third will begin high school.

    But unlike other moms, it's not guaranteed that she'll be there to experience them.

    Lisa, 51, has amyotrophic lateral sclerosis (ALS), a di...

    Know the Signs of Rare Blood Clot Linked With J & J Vaccine

    While U.S. federal government experts probe potential risks of the Johnson & Johnson vaccine, what do you need to know if you have had the one-dose COVID shot or hope to get it?

    Experts at the American Heart Association (AHA) describe what to look out for.

    The U.S. Centers for Disease Control and Prevention and the U.S. Food & Drug Administration paused administration of the J&J (Ja...

    J&J Vaccine 'Pause' Is Not Mandate Against the Shot, FDA Says

    Extremely rare but life-threatening blood clots linked to the Johnson & Johnson COVID-19 vaccine appear similar to those caused by the AstraZeneca vaccine approved for use in Europe and Canada, U.S. health officials said Tuesday.

    Federal officials called for a "pause" in use of the one-dose J&J vaccine while they review data linked to six women between 18 and 48 years of age who developed...