FDA

Superbug tuberculosis treatment gets FDA approval as cases skyrocket

Superbug tuberculosis treatment gets FDA approval as cases skyrocket

The Food and Drug Administration has announced its approval of a vital drug treatment option for the superbug form of tuberculosis, a serious lung disease caused by bacteria. As with certain other conditions related to bacteria, the health care industry has increasingly faced challenges related to drug-resistant tuberculosis that doesn't respond well to standard treatments.

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FDA orders 44 vaping products to be pulled from shelves

FDA orders 44 vaping products to be pulled from shelves

The Food and Drug Administration has ordered 44 vaping products, including items sold for hookahs and e-liquids, to be pulled from shelves in the United States. These products can't be legally sold, according to the agency, because the companies behind them do not have the proper marketing authorization. The news arrives amid the FDA's ongoing investigation of a possible link between vaping and seizures.

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Vaping concerns grow as FDA probes 127 seizure and neurological cases

Vaping concerns grow as FDA probes 127 seizure and neurological cases

In early April, the Food and Drug Administration (FDA) issued a small advisory warning that it had received some reports of seizures possibly linked to electronic cigarette use. At the time, the FDA said it had identified 35 cases associated with vaping; in an update published today, the agency said that number has jumped to 127. In addition to seizures, the FDA warns that some neurological issues may be linked to vaping.

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FDA cracks down on CBD products sold for pain and other health issues

FDA cracks down on CBD products sold for pain and other health issues

The 2018 Farm Bill caused a massive spike in the CBD market, one that now includes a variety of products containing CBD as an ingredient. Some of these CBD products are sold with marketing that claims vast health benefits, ones unproven and often predatory, including promises of curing cancer, preventing Alzheimer's, and sending chronic diseases into remission. The FDA has had enough and is cracking down on such claims.

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FDA warns taco seasoning recalled over Salmonella contamination risk

FDA warns taco seasoning recalled over Salmonella contamination risk

If you're planning to make tacos this weekend using premade taco seasoning packets, beware: the FDA is alerting the public to two recalls involving Walmart-brand and HEB taco seasonings over the risk of Salmonella contamination. The recall was voluntarily initiated by Williams Foods of Kansas, according to the agency, as a precautionary step to ensure no one contracts the potentially deadly illness.

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The FDA just fast-tracked this new blood cancer treatment

The FDA just fast-tracked this new blood cancer treatment

The Food and Drug Administration has announced that it will fast-track the approval of a drug called selinexor sold under the brand name Xpovio for the treatment of a type of blood cancer called relapsed refractory multiple myeloma (RRMM). The approval will only be granted for certain adult patients who haven't responded well to other treatment options.

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FDA warns thousands of wireless insulin pumps can be hacked

FDA warns thousands of wireless insulin pumps can be hacked

The Food and Drug Administration has alerted the public to a new recall from Medtronic concerning the maker's MiniMed insulin pumps. According to the company, some of these MiniMed pumps have a critical cybersecurity issue that cannot be patched, leaving them permanently vulnerable to hackers who wirelessly access them. These recalled pumps were sold in the United States and internationally.

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Blood pressure drug recall expands again: What you need to know

Blood pressure drug recall expands again: What you need to know

The ongoing blood pressure medication recall has been expanded once again, the FDA announced this week. The expansion covers the hypertension drug losartan potassium, some batches of which were found to have unacceptably high levels of an impurity that may cause cancer in some patients. The latest expansion covers 32 batches of the tablets, but the FDA warns you shouldn't stop taking them.

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FDA exposes millions of medical device malfunctions kept secret from public

FDA exposes millions of medical device malfunctions kept secret from public

The FDA has formally ended its controversial Alternative Summary Reporting (ASR) program, which provided some manufacturers with exemptions related to reporting individual medical device reports. With that program now scrapped, the FDA has also posted ASR data that was submitted to the agency from 1999 through 2019, enabling the public to download all of that information via 20 individual zip files.

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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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