FDA

FDA reveals change that’ll help bring cheaper generic drugs to the US

FDA reveals change that’ll help bring cheaper generic drugs to the US

The FDA is moving forward on plans to lower drug costs by streamlining the development and approval of generic medications, the agency said on Tuesday. A push for the faster development of generic alternatives to name-brand medication came from former FDA commissioner Dr. Scott Gottlieb, an effort that remains under acting commissioner Ned Sharpless.

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Another blood pressure drug tests positive for cancer-causing compound

Another blood pressure drug tests positive for cancer-causing compound

Another high blood pressure drug is facing a recall over the discovery of unacceptably high levels of an impurity that may cause cancer in some patients, according to a new report. The warning about the impurity comes from the pharmacy Valisure, which informed the FDA last week about high levels of a substance called dimethylformamide, which is a common solvent used for chemical reactions.

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FDA warns fecal transplants may contain deadly drug-resistant bacteria

FDA warns fecal transplants may contain deadly drug-resistant bacteria

The FDA has issued a new advisory that reveals one patient has died as a consequence of an investigational fecal microbiota transplant (FMT). Though the agency doesn't oppose these investigational studies into the potential benefits of FMTs, it warns that there are serious risks associated with undergoing the treatment, namely the transmission of bacteria that is resistant to a variety of drugs.

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Blood pressure medication recall expands over cancer risk

Blood pressure medication recall expands over cancer risk

The FDA has announced that Teva Pharmaceuticals USA is expanding its voluntary recall of high blood pressure medication losartan potassium. The recall started on April 25 in the US, and has now been expanded to cover another six lots of bulk losartan potassium USP tablets. The recall is due to an impurity that may cause cancer in some high blood pressure patients.

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Vaping firms get nicotine warning as Feds target influencer promos

Vaping firms get nicotine warning as Feds target influencer promos

US watchdogs are cracking down on vape liquid firms using social media influencers to push e-cigarette products, warning several brands over missing health disclaimers. The move comes after the US Food & Drug Administration (FDA) and Federal Trade Commission (FTC) announced they'd be going after companies pushing e-liquid products on kids, part of a crackdown in general on vaping.

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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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