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First FDA-Approved Fecal-Based Treatment Helps Fight a Tough Superbug

The U.S. Food and Drug Administration on Wednesday approved the first fecal microbiota treatment, aimed at helping adults battling tough-to-treat Clostridium difficile (C. diff) infections.

"Today's approval of Rebyota is an advance in caring for patients who have recurrent C. difficile infection [CDI]," said

  • Cara Murez HealthDay Reporter
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  • December 1, 2022
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  • FDA Moves to Ease Restrictions on Gay Men Giving Blood

    THURSDAY, Dec. 1, 2022 (HealthDay News) – U.S. Food & Drug Administration policies that have limited blood donations from men who have sex with men may soon ease.

    At the moment, FDA policy does not allow blood donation from men who have had sex with other men in the past three months. That's already a shorter timeframe than in the past, when the agency required a one-year gap.

    The...

    Berry Good for You: Some Foods Can Strengthen Your Brain

    Eating more berries and drinking tea may help slow mental decline as you age, new research suggests.

    In a study of more than 900 adults, researchers found that foods like these -- containing antioxidant flavonols -- delivered brain benefits to older adults. Flavonols are found in fruits like berries, green leafy vegetables, tea and wine.

    For example, people who ate a serving o...

    A Gene Therapy for Hemophilia That Costs $3.5 Million Gets FDA Approval

    People with one form of the genetic blood disorder hemophilia now have a one-time treatment with a $3.5 million price tag.

    The U.S. Food and Drug Administration approved the new gene therapy Hemgenix on Nov. 22. Soon after, drugmaker CSL Behring revealed its cost.

    The company said its drug would ultimately reduce health care costs because patients with the genetic disorder would ne...

    FDA Approves First Drug to Delay Onset of Type 1 Diabetes

    The U.S. Food and Drug Administration on Thursday approved the first drug that could delay the development of type 1 diabetes (T1D).

    Teplizumab (Tzield) targets the autoimmune issues that drive the disease, rather than its symptoms, making the medication a game changer.

    “Today’s approval of a first-in-class therapy adds an important new treatment option for certain at-risk patie...

    Using an Online Pharmacy to Buy Meds? It's Buyer Beware, FDA Says

    It might be tempting to buy prescription medication online, but buyers should beware, the U.S. Food and Drug Administration warns.

    While some pharmacy websites operate legally and can offer convenience, privacy and lower costs, others may be selling unapproved, counterfeit and unsafe medications, the

  • Cara Murez HealthDay Reporter
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  • November 18, 2022
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  • FDA Approves First Lab-Grown Meat Product

    Americans could soon be eating chicken that’s grown in a lab from cultured animal cells, rather than raised at a farm or facility.

    The U.S. Food & Drug Administration announced Wednesday that the environment-friendly chicken made by California-...

    FDA Moves Toward Making Overdose Antidote an Over-the-Counter Drug

    The U.S. Food and Drug Administration appears poised to approve certain naloxone products for over-the-counter use, a move that would help fight the nation’s opioid epidemic.

    Naloxone (Narcan, Evzio) can save lives when administered soon after the first signs of an overdose from opioids such as heroin, fentanyl, oxycodone or morphine.

    On Tuesday, the FDA

  • Cara Murez HealthDay Reporter
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  • November 16, 2022
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  • FDA Warns of Animal Tranquilizer in Illicit Drugs

    The U.S. Food and Drug Administration on Tuesday warned health care workers to look out for patients who may have been exposed to a potentially deadly animal sedative, possibly through illicit drug use.

    The veterinary medication xylazine is sometimes added to fentanyl, heroin or other drugs, after either being diverted from the legal animal supply or illicitly produced, the FDA said.

    ...

    FDA Warns of Amoxicillin Shortage

    MONDAY, Oct. 31, 2022 (HealthDay News) – It could be harder to fill a prescription for the widely used antibiotic amoxicillin because of a shortage that appears to be linked to an ongoing surge in RSV infections across the United States.

    Supplies of amoxicillin oral solution, which is typically used in chil...

    What Parents Need to Know About Cronobacter Bacteria in Baby Formula

    Cronobacter sakazakii has been in the news as the cause of infant infections and the reason for a U.S. baby formula recall and resulting shortage this year.

    Infections are rare and the bacteria is harmless for most people. Yet it can be dangerous or even life-threatening for infants, especially those who ar...

    Dove, Tresemme Dry Shampoos Recalled Due to Possible Carcinogen

    Unilever announced Monday that it has recalled certain dry shampoo sprays because they may contain elevated levels of benzene.

    The propellant used in the products, which are sold under the brand names Dove, Nexxus, Suave, TIGI (Rockaholic and Bed Head) and TRESemmé, appears to be the source ...

    FDA Panel Votes for Removal of Drug Meant to Prevent Preterm Births

    A U.S. Food and Drug Administration advisory committee on Wednesday voted to recommend that a controversial drug meant to prevent premature births be pulled from the market.

    FDA officials have said they want to withdraw...

    FDA, Company Square Off in Hearing Over Drug Meant to Prevent Preterm Births

    In a three-day hearing that began Monday, a U.S. Food and Drug Administration advisory committee will give the maker of a drug meant to prevent premature births a chance to show why its drug should not be pulled off the market.

    FDA officials have

  • Cara Murez
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  • October 17, 2022
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  • FDA Approves New Bivalent COVID Booster for Use in Children

    The new bivalent COVID-19 booster is now approved for children as young as 5 years old, the U.S. Food and Drug Administration announced Wednesday.

    The bivalent booster shot includes one part that protects against the original strain of the COVID-19 coronavirus, and another part that targets the hi...

    FDA Approves New ALS Drug Despite Uncertain Data

    The U.S. Food and Drug Administration on Thursday gave its approval to a new drug for ALS (amyotrophic lateral sclerosis), also known as Lou Gehrig's disease.

    But appro...

    Less Salt, More Whole Grains: FDA Updates Food Label Definition of 'Healthy'

    Salmon can't be labeled a "healthy" food under existing federal regulations, because it contains high levels of fat.

    But sweetened cereals can bear the "healthy" label on their packaging if they tick specific boxes related to individual nutrients -- even though they might be loaded with added sugars.

    These contradictions fly in the face of modern nutrition science and common sense,...

    Nutrition Labels to Move to Front of Packaging Under Biden Plan

    To help consumers ascertain the nutritional value of foods more easily, the Biden administration said Tuesday it will propose putting nutrition labels on the front of packaging instead of on the back.

    The proposal will be paired with an update on criteria for wha...

    FDA Warns of Cybersecurity Risk With Certain Medtronic Insulin Pumps

    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...

    FDA Approves Botox Competitor That Lasts Longer

    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,...

    Dogs Have Died After Licking a Common Chemotherapy Cream, FDA Warns

    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...

    CDC's Expert Panel OKs Omicron-Specific Booster Shots From Pfizer, Moderna

    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...

    FDA Warns of Dangers From Skin Lightening Creams

    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...

    FDA Approves Omicron-Specific Booster Shots From Pfizer, Moderna

    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...

    Could Black Tea Lengthen Your Life?

    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...

    Thousands of U.S. Patients Got COVID Treatments Rejected as Useless by FDA

    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.

    ADHD Drug Adderall in Short Supply

    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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  • U.S. Government Extends Baby Formula Waivers, Rebates for WIC Families

    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 Asks FDA to Approve Omicron-Specific Booster Shot

    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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  • Brain-Eating Amoeba May Have Caused Nebraska Child's Death

    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...

    FDA Issues Warning to Maker of Illegal Nicotine Gummies

    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...

    Cheaper Over-the-Counter Hearing Aids Should Be in Stores by October, FDA Says

    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...

    Common Diabetes Drug Januvia May Contain Traces of Carcinogen, FDA Says

    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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  • U.S.-Russia Nuclear War Could Leave 5 Billion Dead Due to Famine

    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...

    B 8/10 -- FDA Warns Amazon, Other Vendors About Sale of Skin Tag Removal Products

    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...

    FDA to Take a Hard Look at Its Food, Tobacco Programs

    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...

    More Hospitalizations, Illnesses From Daily Harvest Crumbles

    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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  • Chicken Strips Dog Treats Recalled Due to Salmonella Danger

    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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  • Florida Company Recalls All Ice Cream Products Over Possible Listeria Contamination

    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...

    FDA Mulling Over-the-Counter Sale of Contraceptive Pill

    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 Clams Recalled Due to PFAS Chemical

    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,...

    U.S. Opens Baby Formula Market to Foreign Suppliers

    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...

    FDA Allows Pharmacists to Prescribe COVID Drug Paxlovid

    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.<...

    FDA Temporarily Suspends Ban on Juul E-Cigarettes

    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...

    FDA Tells Vaccine Makers to Update Boosters to Target Omicron Subvariants

    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...

    Pool Neck Floats a Danger to Babies, FDA Warns

    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...

    FDA Panel Supports Rollout of Tweaked Booster Shots From Moderna, Pfizer This Fall

    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...

    FDA Panel to Weigh Improved Booster Shots From Moderna, Pfizer

    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...

    After Appeal, Court Rules Juul Can Still Sell E-Cigarettes for Now

    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...

    FDA Bans Juul E-Cigarettes From US Market

    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...