FDA

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FDA Approves First Medication as a Sleep Apnea Treatment

Next question will be about Medicare and other insurance coverage

(Newser) - The FDA has granted approval for its first medication for certain patients with sleep apnea—the weight-loss drug Zepbound. The decision could lead to expanded insurance coverage of the medication, CNBC reports; plans often don't include weight-loss drugs. Eli Lilly, the manufacturer, said Friday that Zepbound should be used...

FDA Updates Rules for 'Healthy' Food Labels
FDA Redefines 'Healthy' Food
Dec 19, 2024 7:05 PM CST

FDA Redefines 'Healthy' Food

Definition had not changed in 30 years

(Newser) - Packaged foods in the US will have to follow new rules in order to call themselves "healthy," according to changes finalized Thursday by the Food and Drug Administration. It's an update of the agency's definition originally devised 30 years ago, the AP reports. The move is...

SCOTUS Takes Up FDA Ban on Yummy Flavored Vapes

Some argue overturning the ban 'would be a real harm to public health'

(Newser) - Vaping is coming before the Supreme Court next week as federal regulators ask the high court to uphold its block on sweet, flavored products following a spike in youth e-cigarette use, per the AP . The Food and Drug Administration has denied more than a million marketing applications for candy- or...

On Popular Asthma Pill, 'Something That's Concerning'

FDA ties Singular (aka montelukast) to mental health issues; it's not necessarily cause-effect

(Newser) - When Merck debuted its Singulair asthma pill in the late '90s, an appealing alternative to asthma sufferers who relied on inhalers, the pharmaceuticals company compared it to a "sugar pill" in terms of side effects, calling any distribution of the drug to the brains of the millions of...

Trump Makes Flurry of Picks, Including a Moderate

Rep. Lori Chavez-DeRemer nominated for labor; others named for HUD, CDC, and surgeon general

(Newser) - President-elect Trump is having a busy night filling out his administration. After announcing Scott Bessent as his nominee to be treasury secretary , Trump made a flurry of other picks, per the AP :
  • Labor: Trump picked Rep. Lori Chavez-DeRemer, an Oregon Republican, as his labor secretary. "I look forward to
...

Anti-Anxiety Drug Recalled Because of Dangerous Misprint

Company says some cartons of Clonazepam list incorrect strength on packaging

(Newser) - A drug used to treat anxiety, seizures, and muscle spasms has been recalled because of a misprint the FDA says could be "life-threatening." Fox News reports that Endo, Inc. has expanded a recall of Clonazepam because the cartons have been printed with the incorrect strength. People prescribed the...

Tom's of Maine Gets Into a Little Trouble With the FDA

Agency found bacteria, mold in a May inspection at a plant in Sanford, Maine

(Newser) - Tom's of Maine has found itself on the wrong side of the Food and Drug Administration. An inspection earlier this year at a plant in Sanford, Maine, surfaced a number of violations. As CNN reports, in a letter dated Nov. 5, the agency says inspectors found the following in...

FDA Agrees Ingredient in Cold Medicines Doesn't Work

Agency's advisers already decided oral phenylephrine is ineffective

(Newser) - After what the agency called a thorough review of the data, the Food and Drug Administration has proposed ending the use of an ingredient of many cold and allergy medications because it doesn't work. Oral phenylephrine doesn't ease nasal congestion, the agency said. That's the same conclusion...

Your Food Packaging May Soon Come With a Warning Label

FDA hopes to add warnings signaling high levels of sodium, saturated fat, added sugars

(Newser) - "Eating patterns in the US do not align with federal dietary recommendations." That's per a recent proclamation by the Food and Drug Administration, which warns we're a nation facing "an ever-growing epidemic of diet-related chronic diseases such as cardiovascular disease, diabetes, and obesity." One...

Report: FDA Has Fallen Far Behind in Drug Plant Checks

More than 2K plants are overdue for inspection

(Newser) - Federal regulators responsible for the safety of the US drug supply are still struggling to get back to where they were in 2019, before the COVID-19 pandemic upended factory inspections in the US and across the world. An AP analysis of Food and Drug Administration data shows that agency staffers...

Updated COVID Shots to Be Available in Days
New COVID Shots Are Coming
Aug 22, 2024 3:44 PM CDT

New COVID Shots Are Coming

FDA clears vaccines, and Pfizer and Moderna are ready to ship

(Newser) - Federal regulators approved updated COVID-19 vaccines on Thursday, shots designed to more closely target recent virus strains—and ideally whatever variants cause trouble this winter, too. With the Food and Drug Administration's clearance, Pfizer and Moderna are set to begin shipping millions of doses, which should be available in...

Veggies Sold at Walmart, Kroger, Aldi Under Recall

More than a dozen vegetables, herbs out of Ohio's Wiers Farm may pose listeria risk

(Newser) - Summer is fruits and veggies time, but if you've picked up any of the latter lately, you may want to check the latest recall list. ABC News reports that the FDA has announced an expanded recall from Wiers Farm in Ohio that now covers 18 different vegetables and herbs...

The Rise of the Unregulated Home Health Test
The Rise of the
Unregulated
Home Health Test
longform
Jul 20, 2024 5:00 PM CDT

The Rise of the Unregulated Home Health Test

More people are turning to them if doctors aren't giving them answers

(Newser) - From babies with mysterious gastrointestinal issues to adults with unexplained chronic pain, an increasing number of people are turning to unregulated home health tests for answers they're not getting from doctors. The Washington Post delves into the phenomenon with the story of Annika Sharma, who, at 6 months old,...

FDA Bans Unsafe Ingredient Found in Some Sodas
So Long to This Controversial
Soft-Drink Ingredient
in case you missed it
Jul 7, 2024 7:30 AM CDT

So Long to This Controversial Soft-Drink Ingredient

FDA to enforce ban on brominated vegetable oil beginning in 2025

(Newser) - Say goodbye to BVO. The FDA announced Tuesday that brominated vegetable oil, the controversial ingredient found in some citrus-flavored soft drinks, will no longer be allowed in food or beverages in the US due to safety concerns. Used to keep citrus flavoring from rising to the top of drinks, the...

On Alzheimer's, an Advance 'We've All Been Waiting For'

Eli Lilly's donanemab, sold as Kisunla, gets the FDA green light to help slow disease progression

(Newser) - Last summer, the Food and Drug Administration gave the thumbs-up to Leqembi, the first drug shown to slow the progression of Alzheimer's disease. Now, almost a year to the day after that move, the government agency has greenlit a second drug: Eli Lilly's donanemab, sold under the brand...

FDA to Bakery: Stop Saying Your Products Have Allergens

Agency says Bimbo has been labeling foods as having allergens that don't actually have them

(Newser) - Federal food safety regulators said Tuesday that they've warned a top US bakery to stop using labels that say its products contain potentially dangerous allergens when they don't. Food and Drug Administration inspectors found that Bimbo Bakeries USA—which includes brands such as Sara Lee, Thomas', Entenmann's,...

Critics Slam FDA, 'Predatory Industry' on Menthol E-Cigs

Parent, anti-smoking groups say first product of its kind will continue to encourage teen vaping

(Newser) - The Food and Drug Administration on Friday authorized the first menthol-flavored electronic cigarettes for adult smokers, acknowledging that vaping flavors can reduce the harms of traditional tobacco smoking. The FDA said it authorized four menthol e-cigarettes from NJOY, the vaping brand recently acquired by tobacco giant Altria, which also sells...

FDA Says Microdosing Candy Bars Are Making People Sick
FDA Says Microdosing Candy
Bars Are Making People Sick
IN CASE YOU MISSED IT
Jun 15, 2024 4:15 PM CDT

FDA Says Microdosing Candy Bars Are Making People Sick

6 people have been hospitalized so far

(Newser) - According to the FDA, a brand of microdosing chocolate bars sent some consumers on a very unwanted trip, and now the agency is warning others not to eat the bars. Eight people so far have reported getting sick after eating one of the bars from Diamond Shruumz, and six of...

FDA Warns of Poisoning From Shellfish in 2 States
FDA Issues Shellfish Warning
Jun 11, 2024 2:28 PM CDT

FDA Issues Shellfish Warning

Toxins have sickened at least 31 people in Oregon alone

(Newser) - The Food and Drug Administration says consumers should avoid eating shellfish from Oregon and Washington state, as they may be contaminated with toxins that cause paralytic shellfish poisoning. At least 31 people have been sickened in Oregon so far, according to state health officials. Here's the situation, per the...

Expert Panel Recommends FDA Approve Alzheimer's Drug

Advisers vote unanimously to back donanemab despite risks

(Newser) - A closely watched Alzheimer's drug from Eli Lilly won the backing of federal health advisers on Monday, setting the stage for the treatment's expected approval for people with mild dementia caused by the brain-robbing disease. Food and Drug Administration advisers voted unanimously that the drug's ability to...

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