FDA

FDA approves $2.1m gene therapy for infants with rare genetic disease

FDA approves $2.1m gene therapy for infants with rare genetic disease

The Food and Drug Administration (FDA) has issued its first approval for a gene therapy treatment targeting young children. The gene therapy is called Zolgensma, and it is designed to treat the rare genetic disease spinal muscular atrophy in children under the age of two. The FDA's Acting Commissioner Ned Sharpless called the approval a 'milestone' for gene therapy.

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FDA approves easier tests for America’s most common STIs

FDA approves easier tests for America’s most common STIs

New, easier tests for two of the most common STIs have been cleared by the US FDA, paving the way for more rapid - and less uncomfortable - diagnosis and treatment. While tests for chlamydia and gonorrhea are already in widespread use, currently they can require relatively intrusive methods of sampling.

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The FDA just approved this futuristic lung transplant technology

The FDA just approved this futuristic lung transplant technology

The Xvivo Perfusion System looks like a medical device out of a science fiction movie, but it's real and it was just granted FDA approval. The technology opens the door to a greater number of lung transplants by enabling teams to evaluate and potentially approve donor organs that would otherwise be discarded. The system was previously approved under a humanitarian device exemption, but that limited the number of patients who could benefit from the technology.

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Don’t blame the measles vaccine for global outbreaks

Don’t blame the measles vaccine for global outbreaks

The measles, a disease that was declared eradicated in the United States nearly 20 years ago, is seeing a massive resurgence across the nation. The CDC issued an advisory earlier this week that warned the US is about to exceed its post-eradication record number of measles cases per year...and it'll probably happen within weeks, not months. Following its lead is the FDA, which has issued a statement emphasizing one important point: the vaccination is not to blame for these outbreaks.

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FDA warns some e-cigarette users have reported seizures after vaping

FDA warns some e-cigarette users have reported seizures after vaping

The Food and Drug Administration has issued an advisory that warns it has received some reports of seizures from e-cigarette users. The majority of the reports involve "youth and young adult users," according to the agency, which says it has noted an "uptick" in voluntary reports about seizures. The FDA is seeking reports from other nicotine vape users who experienced seizures possibly caused by the nicotine use.

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FDA launches anti-smoking ‘One Leaves’ Xbox game for teens

FDA launches anti-smoking ‘One Leaves’ Xbox game for teens

The FDA teamed up with FCB New York, an advertising agency, to launch One Leaves, an anti-smoking Xbox and PC game targeted at teenagers. The game is offered under the tobacco prevention campaign "The Real Cost," and is part of an initiative discouraging teens from picking up the habit. Players are introduced to a horror storyline, one involving, of course, the death and diseases caused by smoking.

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Genetically modified salmon can now be imported into the US

Genetically modified salmon can now be imported into the US

The Food and Drug Administration has ended its 2016 import alert on genetically modified salmon, pointing to its past analysis of evidence related to the fish, as well as its approval of genetically modified salmon from AquAdvantage. The import alert had resulted from Congress, which ordered the FDA to block genetically engineered salmon from entering the US until final labeling guidelines had been issued.

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The FDA just approved this groundbreaking antidepressant nasal spray

The FDA just approved this groundbreaking antidepressant nasal spray

The FDA has announced its approval of Spravato, a ketamine-based nasal spray that can be used with oral antidepressants as a treatment for severe depression. The drug is intended for adults who suffer from treatment-resistant depression and have been unable to find relief through other medications. However, the FDA warns that Spravato's side effects may result in some potentially "serious adverse outcomes," and as such the drug has been limited to a restricted distribution system.

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FDA warns risky plasma infusions from young donors won’t prevent aging

FDA warns risky plasma infusions from young donors won’t prevent aging

The FDA has issued a report warning the public against receiving blood plasma infusions from young donors under the assumption that it will reverse aging or eliminate diseases. The advisory was prompted by reports from several states, according to the agency, about establishments allegedly offering infusions of plasma from young donors under claims of health and medical benefits.

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FDA pilot program will test blockchain to help curb counterfeit drugs

FDA pilot program will test blockchain to help curb counterfeit drugs

The FDA is exploring innovations that could help it track drugs, including blockchain, and it has a new pilot program to test them out. The agency revealed its pilot program in an announcement today, explaining that drug manufacturers, stakeholders, repackagers, and others can test the "emerging approaches" to verifying and tracing prescription drugs in the United States.

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Alphabet’s Verily ECG watch gets FDA approval as medical device

Alphabet’s Verily ECG watch gets FDA approval as medical device

Alphabet unveiled Verily Study Watch in 2017, describing it as a smartwatch designed specifically for capturing health data from clinical study participants. The watch has been put to good use in the months since its launch, including in studies involving Parkinson's disease. The wearable features an on-demand ECG device and has just earned FDA approval as a Class II medical device.

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Romaine lettuce E. coli outbreak source identified as California

Romaine lettuce E. coli outbreak source identified as California

Nearly a week after advising the public about another E. coli outbreak, US officials are back with an update: the source of the contaminated products. According to the Food and Drug Administration, the new E. coli O157:H7 strain that has impacted consumers in both the United States and Canada originated from various romaine lettuce farms in California.

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