FDA

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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... More »

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... More »

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... More »

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... More »

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... More »

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... More »

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... More »

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... More »

Food Inspectors Heading Back to Work Without Pay

FDA inspections of 'high risk' items were to resume

(Newser) - The FDA says it will resume inspections of some of the riskiest foods—such as cheeses, produce and infant formula—that had been briefly halted as a result of the partial government shutdown. FDA Commissioner Scott Gottlieb said Monday that the agency is bringing back about 150 unpaid employees for... More »

Amid Increasing Drug Recalls, FDA Focuses on 2 Factories

Agency: Factories in China, India that made blood pressure drugs have equipment, process problems

(Newser) - With the significant number of drugs and drug ingredients made overseas, it's hard for the FDA to provide airtight oversight. But two plants in China and India that pump out oft-prescribed blood pressure and heart medications are now on the agency's radar after FDA tests revealed trace amounts... More »

Shutdown 'Puts US Food Supply at Risk'

FDA has suspended domestic inspections

(Newser) - The government shutdown has put America's food supply at risk despite the best efforts of the Food and Drug Administration, experts warn. The agency has had to suspend routine testing of most domestic food production facilities, though inspections of imports are continuing. Inspectors working without pay are continuing to... More »

FDA Narrows Its Romaine Lettuce Warning

Lettuce from outside parts of California not linked to outbreak

(Newser) - The Food and Drug Administration has narrowed its warning not to eat romaine lettuce . The agency now says the only growing areas linked to a recent E. coli outbreak are in the Central Coast region of northern and central California and romaine lettuce grown elsewhere is probably safe, USA Today... More »

Major Restrictions on Flavored E-Cigs Are Coming

FDA plans to rid them from convenience stores, gas stations to protect teens

(Newser) - The expected FDA crackdown on a youth vaping "epidemic" is on the horizon, with the New York Times and Washington Post reporting that most flavoured e-cigarettes will be banned from convenience stores and gas stations across the country as early as next week. Menthol and mint flavors will be... More »

Super-Potent Opioid Wins FDA Approval

Dsuvia will be tightly controlled, the FDA promises

(Newser) - It's called Dsuvia, and the potency of this opioid is hard to fathom: It's up to 1,000 times stronger than morphine and up to 10 times stronger than fentanyl, reports USA Today . Despite the worries of critics that it will add to the nation's opioid problem,... More »

The 'Magic' in 'Shrooms Could Really Help You

New study says it can serve medicinal purposes

(Newser) - Want to quit smoking or alleviate depression? In a few years you might be taking the psychedelic "magic" in magic mushrooms—if the FDA ever agrees, the New York Times reports. Researchers from John Hopkins University suggest the FDA should reclassify psilocybin—the psychedelic drug in hallucinogenic mushrooms—to... More »

FDA May Take Drastic Moves to End Teen Vaping 'Epidemic'

Could ban sales if manufacturers don't comply with new requirement

(Newser) - Youth vaping is an "epidemic," as far as the FDA is concerned, and if manufacturers don't submit "robust" plans to prevent kids from getting their hands on flavored e-cigarettes, the agency will take action—possibly going so far as to order the flavored products off the... More »

New EpiPen Competitor Approved by FDA

Generic alternative should hit the market soon

(Newser) - Parents of children with serious allergies may soon get some relief when shelling out for a epinephrine auto-injector. The FDA has approved a generic alternative to Mylan Pharmaceuticals' widely used EpiPen and EpiPen Jr., reports CNN . While other name-brand injectors exist, this one, produced by Teva, is the first approved... More »

FDA Gives OK to Market Pregnancy- Prevention App

Natural Cycles says its technology is 93% effective, but there has been some controversy

(Newser) - "There's an app for that" is making further inroads in the contraceptives arena. USA Today reports the FDA has approved marketing for the Natural Cycles app, which claims it can help prevent pregnancy by telling a woman what days are best for avoiding sex (marked "red" days)... More »

Tainted Water Blamed for Deadly E. Coli Outbreak

Romaine lettuce outbreak is over, feds say

(Newser) - The worst E. coli outbreak in the US since 2006 is over, with five people dead and more than 200 sickened by tainted romaine lettuce, federal authorities say. The outbreak, which affected people in 36 states and caused at least 96 hospitalizations, was traced to the Yuma region in western... More »

FDA: Teething Remedies Can Have Deadly Side Effects

It wants the products taken off shelves

(Newser) - Federal health officials warned parents Wednesday about the dangers of teething remedies that contain a popular numbing ingredient and asked manufacturers to stop selling their products intended for babies and toddlers. The Food and Drug Administration said that various gels and creams containing the drug benzocaine can cause rare but... More »

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