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

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The Supreme Court on Wednesday delayed a decision on a federal appeals court ruling that seeks to limit access to the abortion pill mifepristone.

In a brief order, Justice Samuel Alito Jr. said the pause on any decision would lapse Friday at midnight, giving the court more time to consider the case, the New York Times reported.

The delay suggests there may be disagreemen...

In the latest move to restrict access to the abortion pill mifepristone in the United States, a coalition of anti-abortion groups on Tuesday asked the Supreme Court to allow an appeals court ruling to stand.

That ruling, issued by the Fifth Circuit Court of ...

Seniors and people with weakened immune systems can get another booster dose of the bivalent COVID vaccine this spring, the U.S. Food and Drug Administration announced Tuesday.

Seniors age 65 and older can get a booster at least four months following their first dose of the bivalent vaccine, which protects against both the original and Omicron strains of COVID, the FDA said. People with w...

The Biden administration filed an emergency application on Friday that asks the U.S. Supreme Court to pause parts of a recent federal ruling that limit the availability of the abortion pill mifepristone.

On Wednesday, a federal appeals court partially overruled Judge Matthew Kacsmaryk's ruling in Tex...

A federal appeals court on Wednesday said the abortion pill mifepristone could remain available for now. But the court's judges added some provisions to their ruling: A block on mailing the pill to patients as well as stays on other measures the federal government has taken recently to boost access to the medication.

The three-member panel partially overruled

  • Robin Foster HealthDay Reporter
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  • April 13, 2023
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  • Juul Labs on Wednesday reached a $462 million settlement with several states over the aggressive marketing of its electronic cigarettes to minors.

    This latest settlement includes New York, California, Colorado, the District of Columbia, Illinois, Massachusetts and New Mexico.

    Juul

  • Cara Murez HealthDay Reporter
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  • April 13, 2023
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  • The U.S. Justice Department on Monday appealed a Texas court ruling that invalidates the U.S. Food and Drug Administration's approval in 2020 of mifepristone, the first of two drugs taken during a medical abortion.

    The ruling by U.S. District Judge Matthew Kacsmaryk in Texas is “extraordinary and u...

    A Texas federal judge has issued a preliminary ruling that invalidates the U.S. Food and Drug Administration approval in 2000 of mifepristone, the first of two drugs most commonly taken during a medical abortion.

    Judge Matthew Kacsmaryk added a seven-day stay to his order, issued Friday, to give the...

    The U.S. Food and Drug Administration on Thursday formally withdrew its approval of a drug that was meant to prevent preterm births.

    Sold as Makena, the drug was first approved in 2011 under the FDA's accelerated approval program, but subsequent research questioned the medication's effectiveness and noted serious side effects that included blood clots and depression.

    "It is tragic t...

    Cats constantly licking and chewing because of a skin condition called feline allergic dermatitis may benefit from a new generic treatment approved by the U.S. Food and Drug Administration.

    The FDA approved Modulis for Ca...

    The U.S. Food and Drug Administration on Wednesday approved the over-the-counter use of a nasal spray that can reverse an opioid overdose.

    Research has shown that wider availability of naloxone (Narcan) could save lives as the opioid epidemic rages on in this country.

    “The FDA remains committed to addressing the evolving complexities of the overdose crisis. As part of this work, t...

    A medical device used to diagnose and treat pancreatic and bile duct disease is getting attention from the U.S. Food and Drug Administration after pieces have fallen off and remained in patients' bodies.

    Previously, the FDA had expressed

  • Cara Murez HealthDay Reporter
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  • March 24, 2023
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  • A drug-resistant bacteria linked to recalled eye drops has now killed three people.

    The U.S. Centers for Disease Control and Prevention reported Tuesday that infections with Pseudomonas aeruginosa had led to two additional deaths.

    In all, 68 people have become infected in 16 states. ...

    Perrigo Co., which makes Gerber Good Start SootheProTM Powdered Infant Formula, has recalled the product over concerns about contamination with a potentially dangerous bacteria.

    Cronobacter sakazakii was possibly present between Jan. 2 and Jan. 18 at the company's Gateway Eau Claire, Wisc., manufacturing facility.

    No distributed products have tested positive for the bacter...

    Paxlovid, a medication that has helped millions of high-risk COVID patients avoid hospitalization and death since late 2021, moved one step closer to getting full approval from the U.S. Food and Drug Administration on Thursday.

    An FDA advisory panel voted 16-1 that the Pfizer drug remains a safe and effective treatment and should be given full approval. It has only received emergency use ...

    Migraine sufferers will soon have a new treatment option that works more quickly and may be safer for people at risk of heart attack or stroke.

    The U.S. Food and Drug Administration has approved Pfizer Inc.'s zavegepant (Zavzpret), a nasal spray meant to treat severe headache pain, the company announced Friday.

    “The FDA approval of Zavzpret marks a significant breakthrough for pe...

    New U.S. federal regulations will require mammography facilities to tell women if they have dense breasts, a description of how the tissue looks on the X-ray.

    It can be more difficult to detect cancer in dense breast tissue on a mammogram. Having dense breasts is also a risk factor for developing breast cancer.

    The U.S. Food and Drug Administration update amends regulations issued u...

    Pregnant women will no longer have any drug to prevent preterm birth after the maker of the only available treatment announced Tuesday that it will withdraw its product, Makena, from the market.

    Covis Pharma Group's decision follows a U.S. Food and Drug Administration advisory panel vote last October that concluded the drug does not actually benefit newborns.

    “While we stand by M...

    U.S. Federal health officials have issued recall notices for two more brands of eyedrops.

    In the latest round of recalls, the U.S. Food and Drug Administration posted notices after the companies voluntarily pulled several lots of their eyedrops from the market.

    These recalls do not appear to be connected to other recent recalls or an outbreak in drug-resistant infections, the As...

    Consumers have been using a common over-the-counter oral decongestant known as phenylephrine for years, but that may not continue much longer.

    The U.S. Food and Drug Administration has asked a panel of its advisors to reassess the drug's effectiveness. The medication's safety isn't in question, just whether it actually does what it claims to do.

    The FDA's Nonprescription Drugs Advis...

    Following hours of discussion over safety concerns, a U.S. Food and Drug Administration advisory panel on Wednesday recommended approval of a second RSV vaccine, this one made by GlaxoSmithKline, for use in Americans ages 60 and older.

    The panel's recommendation was based largely on the results of a trial that tested the GlaxoSmithKline vaccine in the same age group. Those findings, publi...

    While adult bed rails are marketed with safety in mind, they need to be used with caution, the U.S. Food and Drug Administration advises.

    "Many death and injury reports related to entrapment and falls for adult portable bed rail products and hospital bed rails have been reported to the FDA and the CPSC [U.S. Consumer Product Safety Commission]," the FDA said in a new

  • Cara Murez HealthDay Reporter
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  • March 1, 2023
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  • In a tight vote, U.S. Food and Drug Administration advisors on Tuesday recommended the approval of an RSV vaccine that could be used in Americans ages 60 and up.

    The vaccine, known as RENOIR, was developed by pharmaceutical giant Pfizer Inc. The same panel of advisors will weigh the potential approval of another respiratory syncytial virus (RSV) vaccine, this one from GlaxoSmithKline, on...

    The U.S. Food and Drug Administration said Tuesday that it has taken action to restrict imports of the veterinary tranquilizer xylazine to prevent illicit use of the drug.

    While veterinarians use products containing xylazine to sedate large animals such as horses and deer, the drug is not safe for people. It is sold on the street under the names tranq, Philly dope and zombie drug.

    F...

    The U.S. Food and Drug Administration's heavily criticized tobacco program promised changes on Friday, including a five-year strategic plan to better outline priorities.

    "As we enter this era of declining use of combustible tobacco and continued innovation in the e-cigarette industry, the societal concerns are not subtle," FDA Commissioner Dr. Robert Califf said in an agency news release...

    Plant-based beverages that use oats, soy, almonds, cashews and other products instead of dairy can continue to call themselves milk.

    The U.S. Food and Drug Administration released new draft rule...

    Stop buying or using Delsam Pharma's Artificial Eye Ointment, the U.S. Food and Drug Administration warned Wednesday.

    The over-the-counter product is made by the same company that makes eye drops that were

    A nasal spray that can reverse an opioid overdose should be sold over-the-counter, two expert panels to the U.S. Food and Drug Administration recommended Wednesday.

    Research has shown that wider availability of naloxone -- brand named Narcan -- could save lives as the opioid epidemic rages on in this country.

    The FDA advisors voted unanimously in favor of making the drug easier to ...

    A nasal spray that can reverse an opioid overdose may become available for easier over-the-counter purchase.

    U.S. Food and Drug Administration advisers are meeting Wednesday to discuss making generic naloxone hydrochloride available without requiring interaction with a pharmacist, CNN reported.

    Approval could happen later this year. Research shows that wider availability of...

    A new treatment for chronic constipation may bring relief without having to use drugs.

    It's a vibrating pill called Vibrant that stimulates the colon as it passes through the body.

    Although the pill was

  • Cara Murez HealthDay Reporter
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  • February 9, 2023
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  • Stung by recent food safety scandals -- most notably last year's infant formula shortage, the U.S. Food and Drug Administration announced Tuesday that it is creating a new unit devoted to food safety.

    The newly dubbed Human Foods Program will wield wide-ranging powers.

    "We're proposing the creation of a unified, newly envisioned organization, called the Human Foods Program, that el...

    Longstanding restrictions on blood donations from gay or bisexual men could soon shift towards a more nuanced policy, where such men are asked about sexual partners and practices instead, the U.S. Food and Drug Administration announced Friday.

    Specifically, gay men who are in monogamous relationships will no longer be required to abstain from sex for any period of time before donating to ...

    The U.S. Food and Drug Administration said Thursday it can't regulate CBD supplements because there isn't enough evidence on their safety. The agency also called on Congress to create new rules for what has become a burgeoning industry.

    "The use of CBD raises various safety concerns, especially with long-term use," FDA Deputy Commissioner

  • Cara Murez and Robin Foster HealthDay Reporters
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  • January 27, 2023
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  • The U.S. Food and Drug Administration's vaccine advisory panel on Thursday voted unanimously to recommend that the agency phase out original versions of COVID vaccines for use in the unvaccinated, in favor of updated bivalent booster shots.

    Committee members also weighed a proposal to streamline the dosing schedule for COVID vaccines by turning them into annual shots that would likely be ...

    A U.S. Food and Drug Administration official who has led the agency's food policy efforts since 2018 announced his resignation on Wednesday.

    Frank Yiannas was also among the top officials leading the agency response to last year's infant formula shortage.

    "Today, I informed [FDA] Commissioner ...

    The U.S. Food and Drug Administration has proposed stricter limits on levels of lead in infant food products.

    The agency announced draft guidance for manufacturers that would lower allowable lead levels in processed foods meant for infants and children 2 years and younger.

    The change could reduce dietary exposure to lead, which can cause neurological and developmental harm, the FDA ...

    The U.S. Food and Drug Administration on Monday asked its vaccine advisory panel to weigh a proposal to turn COVID vaccines into an annual shot for most Americans.

    The committee will weigh the proposal at its Jan. 26 meeting.

    Such a move would simplify future vaccination efforts, a critical point given the fact that efforts to get people to get COVID booster shots have fallen far sh...

    Organic food will soon have to comply with stricter labeling rules under new requirements announced Thursday by the U.S. Department of Agriculture (USDA).

    In what the Organic Trade Organization (OTA) called the biggest change since the USDA's organic program was first founded in 1990, the

  • Cara Murez HealthDay Reporter
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  • January 20, 2023
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  • Adults with asthma now have a new rescue medication to turn to after the U.S. Food and Drug Administration approved Airsupra on Wednesday.

    The drug is the first approved to combine albuterol (a beta-2 adrenergic agonist) and budesonide (a corticosteroid).

    It's mea...

    The U.S. Food and Drug Administration on Friday approved a second Alzheimer's drug, lecanemab, despite reports of rare brain bleeds linked to use of the drug in some patients.

    However, the FDA pointed to the drug's benefits, as well.

    “Alzheimer's disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones,” Dr. Billy ...

    Lecanemab: It's an experimental medication that's been shown in trials to slow cognitive decline in people with Alzheimer's disease.

    It's also up for accelerated approval by the U.S. Food and Drug Administration, with a decision expected by Jan. 6.

    However, the drug has also been linked to two deaths from brain bleeds among people who've used it in trials, so safety concerns could...

    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...