FDA

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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from the FDA follows years of pressure from patient groups and mental health experts who have called the treatment outdated, ineffective, and unethical.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...

Nasal Spray Derived From Party Drug Approved for Depression

Esketamine, for treatment-resistant depression, to be administered by experts

(Newser) - The FDA has approved a new fast-acting depression treatment derived from a party drug . Nasal spray esketamine from Johnson & Johnson's Janssen Pharmaceuticals contains an active portion of the ketamine molecule. As a generic anesthetic, ketamine or "Special K" is increasingly available for depression, but costs a pretty...

Scott Gottlieb Stepping Down From FDA

After almost 2 years leading the agency

(Newser) - Food and Drug Administration Commissioner Scott Gottlieb is stepping down after nearly two years leading the agency's response to a host of public health challenges, including the opioid epidemic, rising drug prices, and underage vaping. Health and Human Services Secretary Alex Azar announced in a statement Tuesday that Gottlieb...

FDA: Beware Letting Robots Operate on You

'Survival benefits to patients when compared to traditional surgery have not been established'

(Newser) - On the plus side: Operations performed using minimally invasive robotic devices can help keep blood loss, pain, and infections to a minimum, reduce scarring, and shorten recovery times. On the minus side, per the Food and Drug Administration: Using these devices for mastectomies and other surgeries for cancers hasn't...

FDA: Beware of Young Blood Transfusions

They're 'potentially harmful,' and claims aren't proven

(Newser) - The FDA has come down hard on young blood transfusions, touted by startups in several states as an anti-aging "cure" that can improve strength, memory, and even reverse the effects of Alzheimer's. Infusions of blood plasma from young donors into older patients "should not be assumed to...

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