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The U.S. Food and Drug Administration is warning patients who use a particular insulin pump system that unauthorized people could access it and change how much insulin a patient receives.

The pump at the center of the FDA alert is the Medtronic MiniMed 600 Series Insulin Pump S...

People wanting to keep wrinkles at bay will soon have a new option now that the U.S. Food and Drug Administration has approved the first competitor for Botox in decades.

Daxxify, made by Revance Therapeutics Inc. in Nashville,...

Your dog may like to lick your hand or face, but if you're using a chemotherapy cream that treats certain skin conditions, you should not allow it, the U.S. Food and Drug Administration advises.

The medication fluorouracil is fatal to dogs when ingested. People who keep the cream on a nightstand or counter sh...

A vaccine advisory panel to the U.S. Centers for Disease Control and Prevention voted on Thursday to recommend updated boosters from Pfizer and Moderna that target Omicron variants, paving the way for the shots to get into American arms within days.

All that is needed now is for CDC Director Dr. Ro...

Skin lightening products can be dangerous for consumers when they contain harmful ingredients that are illegal for over-the-counter sales, the U.S. Food and Drug Administration warned Wednesday.

The potentially harmful ingredient...

The U.S. Food and Drug Administration on Wednesday gave the green light to updated COVID booster shots from both Pfizer and Moderna that target Omicron variants, paving the way for the shots to get into American arms within a few days.

“The FDA has been planning for the possibility that the composit...

A cup of tea can soothe your spirit, but drinking a couple of cups each day may also lower your chances of dying early, new research suggests.

In the study of nearly 500,000 men and women who took part in the U.K. Biobank, researchers found that compared with people who didn't drink tea, those who drank two or more cups a day lowered their risk of dying by 9% to 13%. And it made no differ...

U.S. doctors administered more than 150,000 doses of useless monoclonal antibody treatments to COVID-19 patients early this year, spending loads of cash on therapies that had been deemed of no benefit, a new study has found.

Labor shortages at Teva Pharmaceuticals have made Adderall, a widely used attention-deficit/hyperactivity disorder (ADHD) drug, hard to find in some drugstores.

But the U.S. Food and Drug Administration noted that there's no overall shortage of

  • By Steven Reinberg HealthDay Reporter
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  • August 29, 2022
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  • To help parents who use government nutrition benefits cope with an ongoing shortage of baby formula, U.S. federal officials will extend a program giving them more choice at the grocery store.

    Families who buy formula through the Special Supplemental Nutrition Program for Women Infants and Children (WIC) will be able to buy substitutes for their regular formula through Dec. 31 -- or for 60...

    Pfizer Inc. said Monday that it has asked the U.S. Food and Drug Administration to approve the emergency use of an updated booster shot that targets several versions of the Omicron variant.

    Animal studies show that the new mRNA vaccine produces an immune response against both BA.4 and BA.5 subvariants, with clinical trials set to begin this month, the company said in a

  • By Steven Reinberg HealthDay Reporter
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  • August 22, 2022
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  • The death of a child in Nebraska was likely caused by an infection with a “brain-eating amoeba” that occurred after the child swam in a local river, state health officials announced this week.

    In a news release, officials said it was the first such death eve...

    The U.S. Food and Drug Administration on Thursday warned a maker of nicotine gummies to stop marketing what is an illegal product.

    In what is a first-of-its-kind warning, the agency said it considers these gummies part...

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

    The final rul...

    The popular diabetes drug Januvia may contain traces of a probable carcinogen, but patients should keep using the medication because it could be dangerous to stop taking it, the U.S. Food and Drug Administration announced this week.

    Despite the discovery that Nitroso-STG-19 (NTTP) had been found in some samples of the drug, known generically as

  • By Cara Murez HealthDay Reporter
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  • August 12, 2022
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  • Even a "small" nuclear war, far short of a global conflict, could kill much of the world's population due to starvation, a new study projects.

    Any nuclear war would have obviously devastating effects in the places where it was waged — obliterating cities, instantly killing huge numbers of people, and contaminating local soil and water.

    But the destruction would be expected to stre...

    The U.S. Food and Drug Administration on Tuesday issued warning letters to three companies, including Amazon, for selling unapproved products for removing moles and skin tags.

    No over-the-counter medications hav...

    The U.S. Food and Drug Administration will begin a comprehensive review of its food and tobacco programs amid a high-profile infant formula shortage and recent rulings on e-cigarettes.

    FDA Commissioner Robert Califf first announced the re...

    The U.S. Food and Drug Administration says nearly 100 people have now been hospitalized and hundreds have become ill in at least 26 states after consuming a lentil-based product from Daily Harvest.

    The fallout is mounting for the food delivery company, which first

  • By Ernie Mundell and Robin Foster HealthDay Reporters
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  • July 18, 2022
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  • Dog treats are being voluntarily recalled due to possible salmonella contamination.

    The North Carolina Department of Agriculture & Consumer Services reported July 6 that some Stormberg Foods LLC dog treats were contaminated with salmonella, which triggered

  • By Steven Reinberg HealthDay Reporter
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  • July 14, 2022
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  • Big Olaf Creamery said Wednesday that it is recalling all flavors and all lots of Big Olaf brand ice cream products because they have the potential to be contaminated with Listeria monocytogenes.

    While healthy individuals may only suffer short-term symptoms after infection - including high fever, severe headac...

    For decades, birth control pills in the United States have only been available with a prescription, but an application filed Monday with the U.S. Food and Drug Administration for an over-the-counter pill might change all that.

    The lates...

    Bumble Bee Foods is recalling some canned, smoked clams because they contain high levels of chemicals called per- and polyfluoroalkyl substances (PFAS).

    The voluntary recall, announced July 6,...

    The Biden administration said Wednesday it is taking steps to ensure that international makers of baby formula can continue marketing their products in the United States, to avoid any infant formula shortage in the future.

    The move to help foreign suppliers who have had temporary approval for their formulas will provide consumers with more choices and bolster the industry against future s...

    Patients who test positive for COVID-19 can now get the antiviral pill Paxlovid directly from their pharmacists, the U.S. Food and Drug Administration announced Wednesday.

    The action removes limits that had restricted prescribing authority to health care providers and Test-to-Treat sites.<...

    The U.S. Food and Drug Administration on Tuesday temporarily suspended its ban on e-cigarettes sold by Juul Labs while the company while appeals the agency's action.

    The FDA Center for Tobacco Products wrote on Twitter that "the agency has determined that there are scienti...

    The U.S. Food and Drug Administration announced Thursday that it has asked vaccine makers to update their COVID-19 booster shots to target the Omicron subvariants known as BA.4 and BA.5.

    The two highly contagious subvariants now account for more than half of all new COVID cases in the United States...

    Neck floats marketed for babies to use in water can lead to serious injury or death, the U.S. Food and Drug Administration warned this week.

    The inflatable plastic rings are especially dangerous for infants who have developmental delays or special needs, such as those with spina bifida, spinal muscular atrophy...

    A U.S. Food and Drug Administration advisory panel recommended on Tuesday that updated COVID-19 booster shots be used this fall to protect against Omicron and its highly contagious subvariants.

    Because the virus mutates so quickly, the FDA may approve the new vaccine formulations, since COVID-19 cases are expected to surge again this winter. Tuesday's advisory panel approval speeds the pr...

    A U.S. Food and Drug Administration advisory panel will vote on Tuesday whether to recommend that updated COVID-19 booster shots be used this fall to protect against Omicron and its highl...

    A federal appeals court has ruled that for now, Juul Labs can continue to sell its electronic cigarettes on the U.S. market.

    The Friday ruling came in response to the company seeking a temporary emergency hold while it appeals a ban of its products that was issue...

    The U.S. Food and Drug Administration on Thursday ordered Juul Lab's to pull its e-cigarettes off the American market.

    "Today's action is further progress on the FDA's commitment to ensuring that all e-cigarette and electronic nicotine d...

    The U.S. Food and Drug Administration is poised to pull Juul Lab's e-cigarettes off the American market.

    The decision, which follows a two-year review of reams of data presented by the vaping company, could come as early as Wednesday, sources told the Wall Street Journal.

    The FDA has already

  • By Cara Murez HealthDay Reporter
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  • June 22, 2022
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  • After a final sign-off on Saturday from the head of the U.S. Centers for Disease Control and Prevention, COVID-19 vaccines for children younger than 5 have finally become a reality.

    "This expands eligibility for vaccination to nearly 20 million additional children and means that all Americans ages 6 months and older are now eligible for vaccination," the agency said in a

  • Ernie Mundell and Robin Foster HealthDay Reporters
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  • June 20, 2022
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  • The U.S. Food and Drug Administration's vaccine advisory panel will decide on Tuesday whether to recommend the agency approve the emergency use of Moderna's COVID-19 vaccine in children aged 6 to 17.

    The panel will

    Yet another study shows that ivermectin provides no benefits for COVID-19 patients, but researchers say they'll continue to study a higher dose of the drug.

    Even though the drug used for parasitic infections in animals and people is not approved by the U.S. Food and Drug Administration to treat COVID-19, some have touted it as a therapy against the disease. The

  • By Robert Preidt HealthDay Reporter
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  • June 13, 2022
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  • An experimental drug for the neurological disorder ALS was approved in Canada on Monday, but an ongoing evaluation of the treatment by the U.S. Food and Drug Administration has raised questions about its effectiveness.

    A condition of Hea...

    A U.S. Food and Drug Administration vaccine advisory panel will weigh whether to recommend the emergency use of Novavax's COVID-19 vaccine on Tuesday.

    The decision will be based on

  • By Robert Preidt HealthDay Reporter
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  • June 7, 2022
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  • Beginning June 4, Abbott Nutrition will restart producing baby formula at a shuttered factory that's been central to the ongoing shortage of infant formula in the United States, the company announced on Tuesday.

    The factory in Sturgis, Mich., has been closed since February for what the U.S. Food and Drug Administration called "insanitary conditions." In the first three months of the year...

    Some lots of Jif brand peanut butter are being recalled as health officials investigate a multistate outbreak of Salmonella illness tied to the products.

    Fourteen illnesses (including two hospitalizations) tied to the Salmonella Senftenberg strain of the bacteria have occurred in Arkansas, Georgia, Illinois, Massachusetts, Missouri, Ohio, North Carolina, New York, South Carolina,...

    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 s...

    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 Co...