FDA

FDA advisers recommend EUA for Janssen’s single-shot COVID-19 vaccine

FDA advisers recommend EUA for Janssen’s single-shot COVID-19 vaccine

The Food and Drug Administration's vaccine advisers have officially recommended that Johnson & Johnson's Janssen single-shot COVID-19 vaccine receive an Emergency Use Authorization, which will make it the first single-shot vaccination against SARS-CoV-2 in the US. With this recommendation in place, the EUA is expected to drop any time now.

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This head impact collar that cuts athlete brain injuries just got the FDA nod

This head impact collar that cuts athlete brain injuries just got the FDA nod

An innovative collar intended to prevent athletes from suffering brain injury from head impacts has been given authorization by the FCC to go on sale in the US, with hopes that Q-Collar could help the millions of such injuries that happen each year. Traumatic brain injury (TBI) can lead to nerve damage, paralysis, and even death, when blunt trauma causes the brain to "slosh" in the skull.

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FDA gives Pfizer COVID-19 vaccine go-ahead for easier storage rules

FDA gives Pfizer COVID-19 vaccine go-ahead for easier storage rules

The FDA has allowed more flexible Pfizer COVID-19 vaccine transportation and storage rules, after the pharmaceutical company released new evidence that the drug doesn't necessarily require the ultra-low temperatures first suggested. Pfizer announced the updated findings last week, having initially advised that the vaccine it developed with BioNTech needed to be kept at temperatures between -80ºC and -60ºC (-112ºF to ‑76ºF).

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FDA pulse oximeter warning cautions on COVID-19 blood oxygen testing

FDA pulse oximeter warning cautions on COVID-19 blood oxygen testing

Pulse oximeters used to test blood oxygen levels, an increasingly common precaution during the COVID-19 pandemic, may be giving a false sense of security according to an FDA warning. One of the warning signs of COVID-19 can be low levels of oxygen in their blood, even if they feel well, and a factor that can be an early indicator that medical care is needed.

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Johnson & Johnson 1-shot COVID-19 vaccine gets FDA nod for EUA review

Johnson & Johnson 1-shot COVID-19 vaccine gets FDA nod for EUA review

Johnson & Johnson's single-shot COVID-19 vaccine works against all known variants of the coronavirus, according to new data released today, with the FDA saying the one-dose drug meets its requirements for Emergency Authorization Approval (EUA) review. It's a big step forward for what could be the third vaccine for COVID-19 to be deployed in the US, and one which has a significant advantage over the current Pfizer and Moderna drugs.

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Many cheese products recalled following CDC’s outbreak warning

Many cheese products recalled following CDC’s outbreak warning

Days after the Centers for Disease Control and Prevention published an advisory warning of a Listeria outbreak without a clear source, the FDA has highlighted a new related recall covering a number of Hispanic-style cheese products. The recalled cheese products were sold in several states across the Eastern half of the US.

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Food and food packaging are not a COVID-19 spread risk says FDA

Food and food packaging are not a COVID-19 spread risk says FDA

The coronavirus is highly unlikely to be transmitted via food or food packaging, the US FDA has reconfirmed, as research into the ongoing COVID-19 pandemic reveals more about the potentially deadly disease. Concerns about viral transmission of the infection, and the ways by which it could be transmitted between people, were feverish in the early weeks and months of the pandemic, with widespread fears that COVID-19 could live on food packaging.

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Pfizer COVID-19 vaccine seeks FDA EUA tweak after unexpected good news

Pfizer COVID-19 vaccine seeks FDA EUA tweak after unexpected good news

Pfizer's COVID-19 vaccine is more stable than originally believed, the pharmaceutical company has said today, submitting new evidence for cold temperature storage that could significantly improve access to the drug. Although showing a high success rate in early efficacy trials, Pfizer and BioNTech's vaccine did have one big drawback: it appeared to only remain stable at ultra-cold temperatures.

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More fresh basil recalled over intestinal parasite risk

More fresh basil recalled over intestinal parasite risk

A few months after its last recall, Shenandoah Growers Inc has recalled additional fresh basil products over the risk of contamination with the Cyclospora parasite, which can potentially lead to an intestinal infection called Cyclosporiasis. The voluntary recall has been made 'out of an abundance of caution,' the company says, noting that it involves fresh organic basil packed at its Indianapolis facility.

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FDA warns nasal spray recalled over serious fungal infection risk

FDA warns nasal spray recalled over serious fungal infection risk

The FDA recently highlighted a new recall of nasal spray that is potentially contaminated with yeast, putting vulnerable people at risk of a potentially life-threatening fungal infection. The recall covers one lot of Allercleanse Nasal Spray sold under the brand Manukaguard from NDAL MFG INC. Consumers can return the product for a replacement.

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FDA authorizes a unique daytime gadget to treat snoring and sleep apnea

FDA authorizes a unique daytime gadget to treat snoring and sleep apnea

The FDA has announced marketing authorization for the eXciteOSA device, a unique gadget that is used during the day to help reduce snoring and sleep apnea at night. Ordinarily, both nighttime issues are treated using devices that the patient wears while asleep. eXciteOSA is different: it's a device you use during the day to stimulate the tongue muscle.

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FDA: COVID-19 mutation will require vaccine & test changes but there’s still good news

FDA: COVID-19 mutation will require vaccine & test changes but there’s still good news

COVID-19 mutations have already reached the US and could impact existing vaccines and tests during the pandemic, the FDA has said, confirming that new regulations are being worked on that will hopefully streamline variant-focused updates to healthcare. However the Food and Drug Administration says that, for the moment at least, it believes the risk of mutations on existing molecular testing for coronavirus is low.

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