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Health News Results - 282

A baby formula plant closed in February at the heart of the current U.S. shortage of the product could reopen as soon as next week, U.S. Food and Drug Administration Commissioner Dr. Robert Califf told House lawmakers on Thursday.

The Abbott Nutrition's Michigan formula plant is the largest in the nation, and it was closed due to contamination issues.

Earlier this week, the FDA...

The first underwear meant to protect against sexually transmitted infections during oral sex was approved by the U.S. Food and Drug Administration on Thursday.

Lorals -- which are available as bikinis or shorties -- are made of vanilla-flavored latex about as thin as condom material and form a ...

The U.S. Food and Drug Administration is warning Americans to watch out for phony at-home, over-the-counter COVID-19 tests that look a lot like the real things.

The counterfeit test kits may put you at risk of unknowingly spreading the disease or not seeking appropriate medical treatment, the agency cautions.

The phonies "are made to look like authorized tests so the users will thi...

The U.S. Food and Drug Administration on Thursday released proposed rules — first announced a year ago — to ban menthol cigarettes and flavored cigars.

"The proposed rules would help prevent children from becoming the next generation of smokers and help adult smokers quit," U.S. Health and Human Services Secretary Xavier Becerra said in an FDA

  • Dennis Thompson HealthDay Reporter
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  • April 28, 2022
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  • Twelve companies have been issued warning letters about selling over-the-counter skin lightening products containing hydroquinone, the U.S. Food and Drug Administration announced Tuesday.

    The products are unapproved drugs that are not recognized as safe and effective, according to

  • By Robert Preidt HealthDay Reporter
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  • April 20, 2022
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  • Disability activist Gem Hubbard regularly shares her insights about life in a wheelchair with more than 75,000 Instagram followers, under the handle @wheelsnoheels_, and her YouTube videos boast more than 3.7 million hits.

    Hubbard, who hails from the U.K., is "increasingly known internationally for her work in furthering the horizons of people with and without disabilities,"

  • Dennis Thompson HealthDay Reporter
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  • April 15, 2022
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  • People who suspect they may have COVID-19 could soon find out with a simple breath test that delivers results in three minutes.

    On Thursday, the U.S. Food and Drug Administration granted an emergency use authorization for a device called the InspectIR Covid-19 Breathalyzer. The test, which must be administered by a trained operator, demonstrates a high degree of accuracy while taking up n...

    A new law will ensure that vaping companies making electronic cigarettes using synthetic nicotine, in fruit flavors that appeal to teenagers, can be regulated by the U.S. Food and Drug Administration.

    When the law took effect Thursday,...

    Johnson & Johnson must pay $302 million to the state of California for deceptive marketing of pelvic mesh implants for women, an appeals court ruled on Monday.

    However, that is $42 million less than the $344 million originally assessed in 2020.

    Superior C...

    The United States and Canada are investigating a multistate outbreak of norovirus illnesses linked to raw oysters from Canada.

    Restaurants and retailers should not serve or sell these potentially contaminated raw oysters, which were harvested in the south and central parts of Baynes Sound, British Columbia, Canada, the U.S. Food and Drug Administration said.

  • By Cara Murez HealthDay Reporter
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  • April 5, 2022
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  • Despite months of intense lobbying by patient advocates, federal health officials on Monday posted a largely negative review of an experimental drug for the devastating illness known as amyotrophic lateral sclerosis (ALS).

    In an analysis of Amylyx Pharmaceuticals' drug, known for now only as

  • Dennis Thompson and Robin Foster
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  • March 29, 2022
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  • Advocacy groups are pressing U.S. federal regulators to fast-track approval of an experimental drug treatment for the deadly neurological disease ALS (amyotrophic lateral sclerosis), with a decision expected this week.

    The push to approve the drug, so far just called AMX0035, is based on partial data from cl...

    The U.S. Food and Drug Administration authorized several tobacco-flavored vaping products made by the company Logic on Thursday, and added that it would soon announce whether other big-name brands can continue to sell their products in this country.

    The agency said it has acted on approximately 99% of the nearly 6.7 million e-cigarette products submitted for authorization, including denia...

    The U.S. Food and Drug Administration on Monday gave the green light to the sale of beef from gene-edited cattle.

    "Today's decision underscores our commitment to using a risk and science-based, data-driven process that focuses on safety to the animals containing intentional genomic alterations and safety to the people who eat the food produced by these animals," Dr. Steven M. Solomon, dir...

    A wide range of human food, pet food, medical devices and drug products have been recalled by Family Dollar Inc. due to the risk of salmonella and other hazards associated with a rodent infestation at a company warehouse in Arkansas.

    The U.S. Food and Drug Administration-regulated products were shipped from the Family...

    The U.S. Food and Drug Administration has issued another pointed warning about the dangers posed by tianeptine, an antidepressant that is not approved for any type of medical treatment in the United States.

    Topping the list of possible risks from ta...

    Several powdered infant formula products have been recalled by Abbott Inc., following reports of four infants developing bacterial infections after consuming the products, the U.S. Food and Drug Administration said Thursday.

    "As this is a product used as the sole source of nutrition for many of our nation's newborns and infants, the FDA is deeply concerned about these reports of bacterial...

    In a tight vote, the U.S. Senate on Tuesday confirmed Dr. Robert Califf to once again head the U.S. Food and Drug Administration, ending the agency's year-long stretch without a permanent leader.

    Six Republicans crossed over to support Califf in the Senate's 50-46 vote, while five Democrats opposed him. One senator voted present.

    Califf, a cardiologist and medical researcher, briefl...

    A new lung cancer drug that has only been tested in China was soundly rejected by an advisory panel to the U.S. Food and Drug Administration on Thursday.

    Known as sintilimab, the treatment is a type of immunotherapy that unleashes the immune system to attack tumors. It was developed and tested in China by Innovent Biologics, which entered into an agreement with Eli Lilly that...

    The U.S. Centers for Disease Control and Prevention on Friday gave its full approval to Moderna's COVID-19 vaccine for use in people 18 and older.

    This follows a similar move made Jan. 31 by its sister agency, the U.S. Food and Drug Administration.

    The vaccine, which had before been available for that age group only under emergency use authorization (EUA), will be marketed as Spik...

    A newer type of "clot-busting" medication might be safer than the one long used for treating strokes, a preliminary study hints.

    Researchers found that among nearly 7,900 stroke sufferers, those treated with the drug -- called tenecteplase -- were less likely to suffer life-threatening brain bleeding as a side effect, compared to those given the standard medication alteplase.

    Overal...

    Moderna's COVID-19 vaccine has received full approval for use in people 18 and older, the U.S. Food and Drug Administration announced Monday.

    The vaccine, which has been available for that age group under emergency use authorization (EUA), will be marketed as Spikevax. It's not yet fully approved or authorized for use in people younger than 18.

    This is the second COVID-19 vaccine to...

    MONDAY, Jan. 24, 2022 (healthDay News) -- The U.S. Food and Drug Administration is curtailing the use of two monoclonal antibody treatments that do not appear to work against the highly contagious Omicron variant.

    The combo treatments bamlanivimab/etesevimab and ...

    MONDAY, Jan. 24, 2022 (healthDay News) -- The U.S. Food and Drug Administration may soon curtail the use of two monoclonal antibody treatments that do not appear to work against the highly contagious Omicron variant.

    The treatments made by Regeneron and Eli Lilly performed well against e...

    Online grocery shopping has skyrocketed during the pandemic, but many websites are making it hard to find nutrition information on products, a new study shows.

    In the United States, packaged foods are required to have a nutrition facts label, ingredients list and w...

    A three-month sexual abstinence rule for blood donations from sexually active gay and bisexual men should be dropped by the U.S. Food and Drug Administration, critics urge as the country struggles with a blood shortage.

    Right now, based on the slight chance of infection with HIV, men who have sex with men must abstain from sex with other men for 90 days before being eligible to donate blo...

    The nomination of former U.S. Food and Drug Administration head Dr. Robert Califf to again lead the agency now heads to the full Senate for a vote, after a Senate committee on Thursday voted 13-8 for approval.

    Among those who voted against Califf's nomination were Democrats who expressed concerns about his links to pharmaceutical companies, The New York Times reported.

    No d...

    It's a move that could severely limit the number of people taking the controversial new Alzheimer's drug Aduhelm: Medicare on Tuesday proposed to only cover the cost of the pricey medication for people enrolled in approved clinical trials.

    A final decision on coverage is expected later this year.

    The drug costs $28,200 per year, but that cost will only be covered for participan...

    Swabs that come with at-home rapid antigen COVID-19 tests should be used in the nose and not the throat, the U.S. Food and Drug Administration warns.

    It issued the warning on Twitter in response to reports that some people are using swabs intended for nasal samples to take samples from their throats a...

    Citing the rapid spread of the Omicron variant and the need for protection against it, U.S. federal health officials are shortening the recommended time between the second dose of the Moderna vaccine and a booster shot from six months down to five.

    "The country is in the middle of a wave of the highly contagious Omicron variant, which spreads more rapidly than the original SARS-CoV-2 vi...

    Kelly Fucheck woke up one summer Sunday ready to spend a quiet morning at home with her husband, Glen. Their toddler, Tomas, had spent the night at grandma's house.

    She picked out a pair of comfy pants, but when she tried to put them on, she swayed to the left. Then Kelly noticed a sharp pain in the back of her neck. She felt foggy.

    She went into the bathroom and splashed water on h...

    Following a months-long and unprecedented review, Medicare officials expect to announce within the next couple of weeks whether the program will cover the controversial Alzheimer's drug Aduhelm. The drug's benefits are in question and its annual price tag tops $28,000.

    The U.S. Centers for Medicare and Medicaid Services (CMS) tend to cover with little fanfare most drugs approved by its s...

    Younger adolescents may soon be eligible for COVID-19 booster vaccines, possibly by early next week.

    The U.S. Food and Drug Administration is planning on Monday to broaden booster eligibility to include 12- to 15-year-olds, sources told the New York Times. This would be for the Pfize...

    Early research suggests that some rapid COVID-19 tests may be less able to detect the Omicron variant, the U.S. Food and Drug Administration said Tuesday.

    To come to that conclusion, the agency used samples from patients confirmed to be infected with the Omicron variant to see how well the rapid antigen tests work.

    In a

  • Robin Foster
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  • December 29, 2021
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  • Kid-friendly flavored e-cigarettes are still widely available online and in stores, despite a federal judge's ruling that should have pulled the products off store shelves by early September, a new report shows.

    The judge's ruling follows on U.S. Food and Drug Administration action that is nearly two years old.

    Citing risks to vulnerable children, the FDA first announced in January...

    People who struggle with severe asthma now have a new treatment to get some relief.

    The U.S. Food and Drug Administration has approved an injectable drug called Tezspire (tezepelumab-ekko), which would be administered every four weeks by a health care profession...

    The U.S. Food and Drug Administration on Wednesday approved the emergency use of Pfizer's new antiviral pill Paxlovid in people who are at high risk for severe COVID-19. It's the first approved treatment for COVID-19 meant to be taken at home.

    "Today's authorization introduces the first treatment for COVID-19 that is in the form of a pill that is taken orally -- a major step forward in ...

    Fresh Express packaged salads have been linked to a listeria infection outbreak in eight U.S. states, the U.S. Food and Drug Administration says.

    The outbreak has caused 10 illnesses, one hospitalization and one death. It is under investigation by the FDA, the U.S. Centers for Disease Control and Prevention and local health agencies.

    The illnesses started on dates ranging from July ...

    Access to abortion pills by mail was made permanent by the U.S. Food and Drug Administration on Thursday.

    Patients will be able to have a telemedicine appointment with a provider who can prescribe the pills and send them to the patient by mail, the FDA said in

    Margarine has gotten a bad rap for years, but a U.S. ban on partially hydrogenated oils may have made it a healthier choice than butter, a new study suggests.

    Before the U.S. Food and Drug Administration banned such oils in 2018, margarine...

    The Omicron variant could prompt a reshuffling of the way doctors treat COVID infections in the United States, and antiviral pills will likely lead the way in that redoubled effort, Harvard experts say.

    New antiviral pills developed by Merck and Pfizer are expected to remain effective against the Omicron variant, mostly because they interfere with the ability of the coronavirus to replica...

    “Fights off tumors and alleviates symptoms of chemotherapy," one vape's advertising claims, while another is touted as an "asthma remedy, ADHD remedy, and dementia treatment."

    Don't believe the hype.

    Despite claims that certain vaping products may alleviate health problems, there's no proof that they do -- and they may even cause health issues, the U.S. Food and Drug Administratio...

    Children with hard-to-control asthma may get relief from adding an injectable antibody drug to their standard treatment, a clinical trial has found.

    The drug, called dupilumab (Dupixent), has been available for several years to treat stubborn asthma in adults and teenagers. Based on the new findings, the

  • Amy Norton HealthDay Reporter
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  • December 9, 2021
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  • The U.S. Food and Drug Administration on Thursday approved the emergency use of Pfizer's coronavirus booster shots for Americans aged 16 and 17.

    The move comes as the Delta variant is fueling surges in infections and hospitalizations in some pockets of the country, and the highly contagious Omicron variant starts to spread across the United States.

    "Vaccination and getting a booster...

    The best available treatment for COVID-19 infection just got a lot easier to administer to more people, potentially saving more lives in the process, a new study claims.

    Monoclonal antibodies have been shown to dramatically reduce risk of hospitalization and death if given within five days of developing symptoms of COVID.

    However, there's a big roadblock to this getting this treatme...

    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 ...

    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 conj...

    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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  • 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 Wash...

    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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