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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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  • Full Page
  • 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 Administrati...

    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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  • Full Page
  • 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 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
  • 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 certain seizures and some forms of nerve pain.

    It's known, ...

    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 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...

    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...

    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 ...

    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...

    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-...

    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 t...

    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

    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...

    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...

    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.

    De...

    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 ...

    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 ...

    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...

    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...

    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...

    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...

    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...

    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 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...

    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 ...

    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 ...

    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 ...

    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...