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FDA Panel Mulls Merck's COVID Antiviral Pill

A U.S. Food and Drug Administration advisory panel is meeting Tuesday to weigh both the safety and power of Merck's new antiviral pill in preventing severe COVID-19.

There are already two strikes against the pill: Fresh data from Merck shows that the drug, molnupiravir, isn't as effective as first reported; and FDA documents prepared for the panel meeting show the pill may pose a risk of ...

FDA Approves Imaging Drug That Can Help Surgeons Spot Ovarian Cancers

Early detection of ovarian cancer helps boost a woman's survival, and the U.S. Food and Drug Administration on Monday approved a new imaging drug that can help spot tumors during surgery.

The drug, Cytalux (pafolacianine), is meant to improve a surgeon's ability to detect ovarian cancer while operating on a patient.

It is administered intravenously before surgery and is used in co...

Merck's COVID Pill Appears Effective, But May Pose Pregnancy Risks: FDA

Merck's experimental COVID-19 antiviral pill appears effective, but may pose risks for pregnant women, including birth defects and toxicity to developing fetuses, according to the U.S. Food and Drug Administration.

On Friday morning Merck announced

  • Robert Preidt and Robin Foster
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  • November 29, 2021
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  • Abortion Remains Medically Safe for U.S. Women

    Debate rages over access to abortion, but experts say the collected medical evidence makes one thing clear — it is a fundamentally safe procedure for women.

    Abortion is safer than childbirth and it's also safer than a host of other common procedures — colonoscopy, tonsillectomy and plastic surgery, said Dr. Sarah Prager, a professor of obstetrics and gynecology at the University of Wa...

    Kraft Recalls Powdered Drinks Over Metal, Glass Concerns

    Kraft Heinz Co. announced that it is recalling certain lots of Country Time Lemonade, Tang, Arizona Tea and Kool-Aid powdered drinks because they may contain small pieces of metal or glass.

    The company also

  • Robert Preidt and Robin Foster
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  • November 24, 2021
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  • Full Page
  • Many Psychiatric Patients Are Getting Risky Drug Gabapentin 'Off-Label'

    MONDAY, Nov. 22, 2021 (HealthDay News) -- Most prescriptions for the medication gabapentin are for unapproved uses -- and many patients end up taking it along with drugs that create potentially dangerous interactions.

    That's the conclusion of a new study that looked at "off-label" use of gabapentin. In the United States, the drug is officially approved for treating cert...

    Neurologists' Group Issues Guidance to Families on Controversial Alzheimer's Drug

    Neurologists must make sure Alzheimer's patients and their families understand that the controversial drug aducanumab does not restore mental function, the American Academy of Neurology (AAN) said in new position statement that includes ethical guidelines.

    "Aducanumab is not a cure for Alzheimer's disease, yet since it has been approved by the [U.S. Food and Drug Administration], patients...

    Pfizer Asks FDA for Emergency Approval of Its COVID Antiviral Pill

    Pfizer announced Tuesday that it has asked the U.S. Food and Drug Administration to approve the emergency use of its new antiviral pill in people at high risk for severe COVID-19.

    "With more than 5 million deaths and countless lives impacted by this devastating disease globally, there is an urgent need for life-saving treatment options. The overwhelming efficacy achieved in our recent cli...

    Biden Expected to Name Former FDA Head Dr. Robert Califf to Lead Agency Again

    Despite concerns about his close ties to the drug industry, President Joe Biden is expected on Friday to nominate Dr. Robert Califf, former head of the U.S. Food and Drug Administration, to lead the agency once more.

    Califf, who served during the last year of the Obama administration, has long been a consultant to drug companies and ran a Duke University research center that received fund...

    More Than 2 Million COVID Home Test Kits Recalled Due to False Positive Results

    A recall of Ellume at-home COVID-19 test kits has been expanded to include roughly 2 million of the 3.5 million tests that had been shipped to the United States by last month, the U.S. Food and Drug Administration said Tuesday.

    The original recall, involving 427,000 kits, was first announced in early October due to a "higher than acceptable" rate of false positives. It's a Class I recall ...

    Sales of Unproven, Unapproved Stem Cell Therapies Are Booming

    The sale of unproven and unapproved stem cell treatments has skyrocketed in the United States, according to a new five-year study.

    The study found a fourfold jump since 2016 in the availability of the treatments, which claim to do everything from relieving pain to slowing aging.

    People who use these treatments are needlessly spending thousands of dollars and could be putting their h...

    Do Your Kids Really Need Cough & Cold Meds?

    When children have colds, parents may want to hold off on using cough and cold medicines, the U.S. Food and Drug Administration suggests.

    Most children get better on their own, and cough or cold medicines won't change the natural course of a cold or make it go away faster.

    Also, some cough and cold medicines can have serious side effects, such as slowed breathing, which can be life-...

    We've Been Here Before: How Polio Vaccine Rollout Saved Millions of Young Lives

    An infection that can disable and kill stalks the land, but a brand-new vaccine offers hope that almost everyone, kids included, can evade it. After scientific testing, a nationwide rollout of the vaccine begins.

    Sound familiar?

    As the U.S. government gears up to offer COVID-19 shots to about 28 million 5- to 11-year-olds, high levels of vaccine hesitancy in some corners may make ...

    Dole Recalls Bagged Salads Over ​​Possible Listeria​​ Contamination

    Dole Fresh Vegetables Inc. said Monday it has recalled bags of garden salad sold in 10 states after a bag tested positive for listeria contamination.

    No illnesses have been reported in connection with the recalled salad sold in Alabama, Florida, Georgia, Louisiana, Maryland, Massachusetts, North Carolina, Pennsylvania, South Carolina and Virginia, the company said in a

    FDA Approves Pfizer COVID Vaccine for Kids 5-11

    The U.S. Food and Drug Administration on Friday approved the emergency use of a smaller dose of Pfizer's coronavirus vaccine for children ages 5 to 11, paving the way for 28 million kids across the country to get their shots.

    These youngest Americans can now receive one-third of the adult dose, with two injections given three weeks apart. If the U.S. Centers for Disease Control and Preven...

    Stronger Breast Implant Safety Measures Announced by FDA

    A boxed warning and a checklist of risks that must be shared with patients is among the new breast implant safety measures announced by the U.S. Food and Drug Administration on Wednesday.

    As the FDA "continues to evaluate the overall effects of breast implants in patients, today's actions help ensure that all patients receive the information they need to make well-informed decisions affec...

    FDA Advisors Approve Emergency Use of Pfizer COVID Vaccine in Kids 5 to 11

    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 Says Its COVID Vaccine Works Well in Children Aged 6 to 11

    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 ...

    Pfizer Says Lower Dose of Its COVID Vaccine Protects Younger Children

    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 ...

    Pfizer Vaccine Booster Restores Nearly Full Protection, Company Says

    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...

    Salmonella Outbreak in 37 States Linked to Imported Onions

    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...

    White House Announces COVID Vaccination Plan for Young Kids

    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...

    FDA Eases Access to Cheaper Over-the-Counter Hearing Aids

    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...

    FDA Panel Recommends Approval of Johnson & Johnson Booster Shot

    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...

    FDA Panel Supports Moderna Booster Shot for Older Adults, People at High Risk

    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 FDA Chief Robert Califf a Contender to Head Agency Again

    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...

    FDA Questions Strength of Johnson & Johnson's Booster Shot Data

    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 ...

    FDA Reduces Recommended Salt Levels in Americans' Food

    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...

    Baby Cereal Sold at Walmart Recalled for  Elevated Levels of Arsenic

    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 ...

    FDA Expert Panel to Weigh Approval of Moderna, Johnson & Johnson Booster Shots

    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...

    FDA Authorizes First E-Cigarette

    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 Seeks FDA Emergency Approval for COVID Vaccine in Younger Kids

    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 Expands Recall to Include More Than 463,000 Insulin Pumps

    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...

    Merck to Ask FDA for Emergency Approval of Its New Antiviral Pill for COVID

    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...

    Silver Lining Found in Pandemic: Fewer Teens Are Vaping

    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 Assoc...

    Second Report on Toxins in Baby Foods Finds Continuing Problems

    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 ...

    Delay in Graphic Warning Labels on Cigarettes Cost Lives: Study

    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...

    FDA Approves Pfizer Booster Shots for Seniors, High-Risk Americans

    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...

    CDC Expert Panel to Weigh In on Vaccine Boosters

    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...

    Sleep Apnea Patients Struggle as Common CPAP Machine Is Recalled

    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...

    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 said no to ...

    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 repo...

    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 Administration advi...

    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 b...

    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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  • Full Page
  • 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...