FDA

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FDA Gives Emergency Approval to Sell At-Home Virus Tests

Saliva sample needs to be sent to lab for results

(Newser) - In a step forward for coronavirus tests, the FDA is allowing the sale of the nation's first saliva collection kit for use at home. The test kits have to be ordered by a physician, the New York Times reports, and will sell for about $100. The agency said Friday...

FDA Sped Up Virus Tests. Next Came Fraud

Feds will tighten scrutiny because of 'fraudulent' kits on the market

(Newser) - US regulators on Monday pulled back a decision that allowed scores of coronavirus blood tests to hit the market without first providing proof that they worked, per the AP . The Food and Drug Administration said it took the action because some sellers have made false claims about the tests and...

FDA Permits Emergency Use of Drug for COVID-19 Patients

Remdesivir might help shorten recovery time

(Newser) - US regulators on Friday allowed emergency use of an experimental drug that appears to help some coronavirus patients recover faster. It is the first drug shown to help fight COVID-19, which has killed more than 230,000 people worldwide. President Trump announced the news at the White House alongside Food...

Bleach Peddler: I Wrote Trump About Coronavirus 'Cure'

Mark Grenon links his letter to Trump's remarks about 'disinfectant cure'

(Newser) - "Dear Mr President, I am praying you read this letter and intervene." That's how Mark Grenon says he began a letter to President Trump proclaiming the alleged curative power of industrial bleach—right before Trump went on TV and supported disinfectant as a treatment for the coronavirus,...

2 More Dings Against Drug: an FDA Warning and a Study

Agency cautions hydroxychloroquine should only be used in very restricted settings

(Newser) - The drug once touted by President Trump as a possible "game changer" in the fight against the coronavirus has been the subject of more sobering headlines of late, and the newest one from the Food and Drug Administration doesn't help matters. Per Stat News , the FDA on Friday...

FDA Authorizes Use of Drugs Trump Championed

Scientists say there is little evidence supporting move

(Newser) - Two anti-malaria drugs that President Trump has championed have been authorized for emergency use in treating COVID-19 patients. The Food and Drug Administration issued an emergency use authorization, allowing hydroxychloroquine and chloroquine to be prescribed "when a clinical trial is not available or feasible," Politico reports. Trump has...

FDA 'Roadblock' Slows Hand Sanitizer Production

Ethanol industry want rules to be relaxed

(Newser) - As hospitals and nursing homes desperately search for hand sanitizer amid the coronavirus outbreak, federal regulators are preventing ethanol producers from providing millions of gallons of alcohol that could be transformed into the germ-killing mixture. The US Food and Drug Administration's roadblock has been frustrating the health care and...

Just One Place Shocks Autistic Students. FDA Has Stepped In

Agency bans shock devices, just the 3rd item it's ever banned

(Newser) - Federal officials on Wednesday banned electrical shock devices used to discourage aggressive, self-harming behavior in patients with mental disabilities, the AP reports. The announcement from the FDA follows years of pressure from patient groups and mental health experts who have called the treatment outdated, ineffective, and unethical. The agency first...

Jimmy John's Implicated in 5 Illness Outbreaks

Chain stops selling sprouts after FDA warning about 'adulterated' food

(Newser) - Veggies served by sandwich chain Jimmy John's have been linked to five outbreaks of E. coli and salmonella over the past seven years, affecting consumers in at least 17 states, the FDA said Tuesday. The most recent outbreak saw 22 people in Iowa sickened with E.coli in late...

Trump Promises New Strategy on Underage Vaping

Flavor may be removed from market temporarily

(Newser) - President Trump says the federal government will soon announce a new strategy to tackle underage vaping, promising, "We're going to protect our families, we’re going to protect our children, and we’re going to protect the industry." Trump was vague about what the plan would entail...

FDA Adviser Who Backed Lasik Now Opposes It

'We ignored the data on vision distortions,' expert says

(Newser) - Morris Waxler was so supportive of Lasik that he voted to approve the new eye surgery as an FDA adviser more than 20 years ago. He'd like to change his vote now. As horror stories mounted, CBS reports, "I re-examined the documentation … and I said, 'Wow...

Chains Pull Zantac After FDA Finding

FDA is looking into presence of likely carcinogen

(Newser) - Walgreens and CVS have decided to stop selling Zantac in their stores, two weeks after the FDA said it found low levels of a likely carcinogen in some of the heartburn pills. The drugstore chains said the suspension of sales, which also applies to generics, will be in effect while...

FDA Unveils Graphic Cigarette Warning Labels

Tobacco companies blocked them once and are expected to try again

(Newser) - If the Food and Drug Administration gets its way, cigarette labels in the US are about to get pretty graphic. The agency has unveiled 13 proposed warning labels that would be prominently featured on cigarette packs and in cigarette advertising if approved, reports CNBC . The labels go beyond warning of...

New Treatment for Deadliest Strain of Tuberculosis Is Massively Successful

FDA approves new 3-drug regimen

(Newser) - Good news for those with the deadliest strain of tuberculosis: It no longer has to mean a death sentence. Scientists have discovered a cure for extensively drug-resistant TB, or XDR-TB, and on Wednesday, the FDA "effectively endorsed" it, the New York Times reports. Just a small percentage of people...

Despite 10 Years of Warnings, People Still Drink Dangerous 'Cure'

FDA: Taking sodium chlorite products like Miracle Mineral Solution is basically drinking bleach

(Newser) - It's OK to believe in miracles, but drinking bleach for your ailments isn't going to lead to one. That's effectively what people are doing when they quaff a product known as Miracle Mineral Solution, and other products like it that promise a cure for autism, cancer, HIV,...

FDA: Data Manipulated Before Approval of $2.1M Drug

Novartis could face civil, criminal penalties

(Newser) - US regulators want to know why Novartis didn't disclose a problem with testing data until after the Swiss drugmaker's $2.1 million gene therapy was approved. The Food and Drug Administration said Tuesday the manipulated data involved testing in animals, not patients, and it's confident that the...

New Drug Could Cure Horrible Disease. Now, Brace Yourself
New Drug Could Cure Horrible
Disease. Now, Brace Yourself
in case you missed it
May 11, 2019 4:53 PM CDT

New Drug Could Cure Horrible Disease. Now, Brace Yourself

Novartis AG is expected to sell Zolgensma for $2M per treatment

(Newser) - A new wonder drug is coming for babies with a crippling, often fatal disease. Expected price tag: $2 million per treatment, the Wall Street Journal reports. Novartis AG is expected to begin selling Zolgensma, a possible cure for spinal muscular atrophy, after the FDA approves it this month. Novartis executives...

Ambien, Other Sleep Aids Get FDA's Strongest Warning

Injuries and deaths lead to adding 'black box' labels

(Newser) - The FDA is requiring its strongest warning labels be placed on Ambien, Sonata, Lunesta, and other prescription sleep medications. The "black box" label warns that side effects can lead to serious injury or death, Live Science reports. The FDA ordered the change after "rare but serious" incidents among...

First Postpartum Depression Drug: Effective, Cumbersome

Women felt improvement within 24 hours, but need to get it via IV for 60 hours

(Newser) - A groundbreaking treatment has been approved for what doctors say is a major medical condition that doesn't get talked about enough. The FDA has approved brexanolone, the first treatment specifically targeting postpartum depression, which will be sold as "Zulresso," USA Today reports. Doctors say it is much...

Birth Control Pills Recalled Due to Critical Packaging Error

Apotex mistake could lead women to miss pills, or to take placebos instead of active tablets

(Newser) - There's nothing wrong with the tablets themselves, but a nationwide recall of birth control pills has been announced by the Food and Drug Administration due to a packaging goof that could cause women to miss pills or take placebos, possibly leading to pregnancy, People reports. The FDA alert notes...

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