FDA

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It's 'a Difficult Moment for the ALS Community'

Relyvrio being pulled from the market after it was found to be ineffectual for Lou Gehrig's disease

(Newser) - The maker of a drug for Lou Gehrig's disease that recently failed in a large study said Thursday it will pull the medicine from the market, per the AP . Amylyx Pharmaceuticals announced it will voluntarily halt sales and marketing of Relyvrio in the US and Canada, where new patients...

FDA: LSD Is Now a Breakthrough Therapy

Mind Medicine's anxiety-treating MM120 granted designation ahead of Phase 3 trials

(Newser) - The FDA has bestowed breakthrough therapy status on an LSD formulation found to relieve symptoms of anxiety and depression with a single dose. Mind Medicine's MM120 (lysergide d-tartrate) is used to treat generalized anxiety disorder. Twelve weeks after receiving a dose in a Phase 2 trial, 48% of patients...

FDA Delays Approval of Eli Lilly's Alzheimer's Drug
FDA Stalls on New
Alzheimer's Drug
Mar 8, 2024 8:55 AM CST

FDA Stalls on New Alzheimer's Drug

'We were not expecting this,' says Eli Lilly president

(Newser) - Eli Lilly's experimental Alzheimer's drug is facing yet another delay on the path toward FDA approval. The company's donanemab medication was first expected to be cleared last year and later by the end of this month. However, the drugmaker announced Friday that approval isn't expected until...

Lab Wants Recall of Common Acne Meds

They may contain elevated levels of a cancer-causing chemical

(Newser) - An independent lab is calling on the FDA to suspend sales of benzoyl peroxide after finding the acne medication degraded into a cancer-causing chemical in products from popular brands like ProActiv and Clearasil. Valisure analyzed 99 acne treatment products containing benzoyl peroxide (BPO). Before heating, the carcinogen benzene was detected...

First Drug for Severe Food Allergies Is Approved

FDA says Xolair can help people with allergies to milk, eggs, nuts, other sources

(Newser) - A medication used to treat asthma can now be used to help people with food allergies avoid severe reactions, says the FDA. Xolair, the brand name for the drug omalizumab, became the first medication approved to reduce allergic reactions caused by accidental exposure to food triggers, per the AP . Patients...

FDA Has a Suspect in Contamination of Applesauce

Though it's not clear what, if anything, US can do to hold him accountable

(Newser) - Authorities have named a suspect in the tainted applesauce pouches that have left more than 400 American children sickened with lead poisoning, but it's not clear what, if anything, can be done to hold anyone accountable. Carlos Aguilera, a cinnamon grinder in Ecuador, is suspected to be responsible, according...

Controversial FDA Decision a Milestone on Drug Prices
Controversial FDA Decision
a Milestone on Drug Prices
the rundown
Jan 5, 2024 11:19 AM CST

Controversial FDA Decision a Milestone on Drug Prices

Agency will let Florida be the first state to import drugs in bulk from Canada

(Newser) - Americans are known to head across the border into Canada to buy their prescription drugs at cheaper costs. Now, for the first time, a state government has received approval to do the same thing on a much larger scale. In a decision described as historic, the Food and Drug Administration...

America Is Fond of CBD, but We Don't Know Much About It

'We don't have a lot of good data on what effects any of these things have, either harmful or beneficial'

(Newser) - CBD use increased 50% in the past four years, according to a new survey published Wednesday in the Journal of the American Medical Association . About 1 in 5 survey respondents said they used CBD in the past year, reports the AP . People who use cannabis are more likely to report...

It's Forecast to Be Bestselling Drug Ever. Now, a Big Caveat
It's Forecast to Be Bestselling
Drug Ever. Now, a Big Caveat
IN CASE YOU MISSED IT
Dec 16, 2023 6:30 AM CST

It's Forecast to Be Bestselling Drug Ever. Now, a Big Caveat

Study results show patients who went off Zepbound for a year regained half of weight lost

(Newser) - The full results from Eli Lilly's study of its newly approved weight-loss drug Zepbound serve as a splash of cold water in the face of those who believed a few dozen weekly injections would cause pounds to melt off and stay off. The FDA approved Zepbound, with the active...

FDA Ties Lead-Tainted Applesauce to Cinnamon

'WaPo' probe finds nearly 120 kids with lead poisoning after consuming applesauce pouches

(Newser) - Back in October, a handful of kids in North Carolina turned up with elevated lead levels in their blood, tied back to the WanaBana brand of applesauce pouches. Now, the Washington Post reveals that nearly 120 children may be victims of such poisoning. The paper reports that, per its own...

In a Breakthrough, FDA Backs Gene Editing Therapy

New sickle cell disease treatments still face obstacles, including cost

(Newser) - Two gene therapies for sickle cell disease received government approval on Friday, one of which could represent a major turning point in medical treatments. To combat the blood disorder, the Food and Drug Administration for the first time endorsed gene editing therapy for humans, the New York Times reports. The...

This Is Why You Shouldn't Bring a Gun Into an MRI

Patient, 57, ended up shot in the butt after sneaking a firearm into the machine

(Newser) - It might seem obvious to most that one probably shouldn't bring a firearm into a large machine with a powerful magnetic field, but one woman learned that lesson the hard way. The Messenger first reported on the "adverse event" cited by the Food and Drug Administration , in which...

Salmonella Infections Linked to Cantaloupe Kill 3

Authorities warn people not to eat pre-cut cantaloupe if they don't know the source

(Newser) - Consumers shouldn't eat pre-cut cantaloupe if they don't know the source, US health officials said Thursday, as the number of illnesses and recalls tied to a deadly salmonella outbreak grows. At least 117 people in 34 US states have been sickened by contaminated cantaloupe, including 61 who were...

FDA Proposes Banning Controversial Pop Ingredient

California has already banned brominated vegetable oil

(Newser) - The Food and Drug Administration might follow California's lead with a ban on a controversial ingredient found in some citrus-flavored soft drinks. CBS News reports that the agency has proposed banning brominated vegetable oil, which has been used in drinks for around a century. The ingredient, which includes bromine,...

FDA: These Eyedrops Could Blind You
FDA Warns:
These Eyedrops
Could Blind You
IN CASE YOU MISSED IT
Nov 4, 2023 4:10 PM CDT

FDA Warns: These Eyedrops Could Blind You

Affected eyedrops should no longer be used, agency warns

(Newser) - US health regulators are warning consumers not to use more than two dozen varieties of over-the-counter eyedrops because of the risk of infections that could lead to blindness, the AP reports. The Food and Drug Administration advisory applies to lubricating drops sold by six companies, including CVS Health, Target, Rite...

It Feels 'Like Being Stabbed All Over.' A New Cure Is Closer

Panel clears CRISPR gene-editing product for sickle cell disease patients; FDA to weigh in

(Newser) - Sickle cell disease is a painful, debilitating, and possibly deadly inherited disorder that currently can only be remedied with a bone marrow transplant. Now, Boston's Vertex Pharmaceuticals hopes exa-cel, its treatment developed with CRISPR Therapeutics, will soon be approved by the FDA following a thumbs-up from a panel of...

If You Had This Fruit Puree Pouch, Get a Blood Test

FDA says some WanaBana products have 'extremely high concentrations of lead'

(Newser) - WanaBana fruit puree pouches might sound like a healthy option for parents to give their kids, but the FDA is warning that anyone who consumed one should get their blood tested for what appears to be "extremely high concentrations of lead." As the New York Times reports, the...

'Toddler Milks' Are Unregulated and Unnecessary

American Academy of Pediatrics weighs in

(Newser) - Powdered drink mixes that are widely promoted as "toddler milks" for older babies and children up to age 3 are unregulated, unnecessary, and "nutritionally incomplete," the American Academy of Pediatrics warns. The drinks, which are touted to parents on TikTok, in television ads, and on other sites,...

CVS Yanks Completely Ineffective Cold Meds

Move comes after FDA found oral phenylephrine to be a useless decongestant

(Newser) - CVS Health is pulling various cough and cold medicines from its shelves after an FDA advisory panel determined the active ingredient doesn't work. Phenylephrine, approved in the 1930s, has long been found in over-the-counter syrups and pills meant to resolve sinus congestion. However, an FDA analysis found the ingredient,...

Japan's Dementia Treatment 'Has Now Entered a New Era'

Country with rapidly aging population OKs its first Alzheimer's drug

(Newser) - Japan's Health Ministry has approved Leqembi, a drug for Alzheimer's disease that was jointly developed by Japanese and US pharmaceutical companies. As the AP reports, it's the first drug for treatment of the disease in a country with a rapidly aging population. Developed by Japanese drugmaker Eisai...

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