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504 Results for search "Food &, Drug Administration".

Health News Results - 504

Children and adults with a rare type of soft tissue cancer will now have a new treatment option that could have a big impact.

The U.S. Food and Drug Administration has approved the immunotherapy drug atezolizumab (Tecentriq) for use in p...

The U.S. Food and Drug Administration's approval process for the controversial Alzheimer's drug Aduhelm was "rife with irregularities," despite lingering doubts about the power of the pricey medication to slow the disease down, a Congressional report released Thursday claims.

Actions the agency took with Biogen, maker of Aduhelm, "raise serious concerns about FDA's lapses in protocol," th...

With flu rampant in the United States, the U.S. Food and Drug Administration is warning consumers to be wary of over-the-counter products that promise to cure you of influenza, prevent it or reduce its severity.

Sellers offering these products may make claims that are not accurate or safe, the FDA cautions.

"These products can be found online, including popular marketplac...

Call it a good idea that seems to have backfired: A tough new labeling law that requires even the smallest amount of sesame be listed on food products has instead spurred some companies to add it to their products.

The new federal law goes into effect on Jan. 1, adding sesame to the list of major al...

The U.S. Food and Drug Administration's tobacco unit is “reactive and overwhelmed,” an expert panel reviewing its work reported Monday.

In addition, the panel blamed the FDA's inconsistent regulation efforts for the spread of unauthorized e-cigarettes that are appealing to teens, among other problems.

Commissioned by FDA chief

  • Cara Murez HealthDay Reporter
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  • December 20, 2022
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  • Patients with a high-risk bladder cancer now have a new option to treat it.

    The U.S. Food and Drug Administration on Friday approved a gene therapy called Adstiladrin, which is designed to work for patients who have what's called high-risk non-muscle-invasive bladder cancer (NMIBC) that hasn't responded to the standard treatment, Bacillus Calmette-Guérin (BCG), but hasn't spread. BCG is ...

    Owners whose cats have diabetes now have a new option to care for the condition in their otherwise healthy pets.

    The U.S. Food and Drug Administration on Thursday approved the first pill to improve control of diabetes in some cats.

    The drug, call...

    The updated bivalent COVID-19 boosters are now approved for use in children as young as 6 months of age, the U.S. Food and Drug Administration announced today.

    Children can receive either a Moderna or Pfizer-BioNTech bivalent booster shot, although the rules differ depending on their age and what type of vaccine they got as their primary series, the FDA said.

    Kids 6 months to 5 year...

    Lasik eye surgery is a common vision-correcting procedure that many Americans view as safe and effective, but the U.S. Food and Drug Administration has now drafted guidance that warns of potential complications.

    Although many patients are happy with the results after surgery, the recommended new guidance says complica...

    A proposed U.S. federal ban on menthol cigarettes doesn't go far enough and needs to include other menthol products, from pipe tobacco to cigarette tubes, researchers say.

    New evidence shows both the appeal and the addiction potential of these substitutes in adults who smoke menthol cigarettes, said scientists from Rutgers University Center for Tobacco Studies in New Brunswick, N.J., and...

    The U.S. Food and Drug Administration's foods program is in “constant turmoil” and needs stronger leadership, a panel said Thursday.

    The Reagan-Udall Foundation, a group with close ties to the FDA, released a 51-page report Tuesday noting the need for a clear mission in the program ...

    When the U.S. Food and Drug Administration banned fruit-flavored vaping products in early 2020, the idea was to reverse the rapid rise in electronic cigarette use among youths.

    Now, a new survey of adult e-cigarette users finds that instead of quitting e-cigarettes, most vapers switched to flavored products not covered by the ban, or even went back to smoking traditional cigarettes.

    Infants and young children could soon receive an updated COVID-19 vaccine as part of their three-dose series.

    Pfizer Inc. on Monday asked the U.S. Food and Drug Administration to have the vaccine that targets the Omicron subvariants BA.4 and BA.5 replace the third dose in the series for children aged 6 months through 4 years old. Children in that age group would still receive two doses o...

    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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  • 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 agency is now considering switching to ques...

    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...

    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...

    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 patient...

    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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  • 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-ba...

    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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  • 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.

    ...

    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 children, are low, the U.S. Food and Drug Admin...

    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...

    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 ...

    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...

    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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  • 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...

    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...

    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,...

    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...

    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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