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FDA approves 1st flu and COVID-19 combo home test

FDA authorizes 1st over-the-counter combo flu and COVID test outside of emergency use

The FDA has authorized the first over-the-counter combination COVID-19 and flu test outside of emergency use, which delivers results at home in about 15 minutes.

FierceBiotech · 4h

FDA clears at-home COVID/flu combo test with eye on fall season

The FDA has given a green light to an at-home test that checks for both COVID-19 and the flu—a first for the agency, outside of the additional authorities that it received during the coro | Previous over-the-counter tests had been granted emergency authorizations.

MarketWatch · 20h

FDA Authorizes Marketing of First Home Flu and COVID-19 Combination Test Outside of Emergency Use Authorities

Today, the U.S. Food and Drug Administration granted marketing authorization for the Healgen Rapid Check COVID-19/Flu A&B Antigen Test. The test, authorized for use without a prescription, is for use by individuals experiencing respiratory symptoms and uses a nasal swab sample to deliver at-home results in approximately 15 minutes for COVID-19 and influenza (flu).

Yahoo · 15h

FDA approves first flu and COVID-19 combo home test

The authorization allows individuals to purchase the test over the counter without a prescription. The home test, which checks for the flu and the COVID-19 virus, uses a swab to collect a sample from the nose and gives results in about 15 minutes.

Lilly, FDA

FiercePharma · 4h

Compounders sue FDA for removing Eli Lilly's tirzepatide from shortage list

With an estimated 2 million people in the United States taking copycat vers | A compounding industry group has sued the FDA, claiming its action to remove Eli Lilly’s Mounjaro and Zepbound from its drug shortage list is a “reckless and arbitrary decision—lacking any semblance of lawful process.

Bloomberg L.P. · 19h

Lilly Weight-Loss Drug Copycat Makers Sue FDA Over Shortage End

A group representing companies that made copycat versions of Eli Lilly & Co.’s weight-loss drugs sued the US Food and Drug Administration over the agency’s decision to remove Lilly’s medications from its shortage list.

U.S. News & World Report · 22h

Compounding Group Sues FDA for Removing Lilly's Weight Loss Drug From Shortage List

A drug compounding industry group on Monday sued the U.S. Food and Drug Administration over its decision to take Eli Lilly’s blockbuster weight loss and diabetes drugs from its shortage list last week,

FDA Upgrades Ongoing Egg Recall to the Highest Risk Level

Yahoo · 2h

FDA Upgrades Ongoing Egg Recall to the Highest Risk Level Over Possible Salmonella Contamination

The Food and Drug Administration has upgraded an ongoing egg recall alert to Class I, meaning the recalled product "will cause serious adverse health consequences or death.” The recall was initiated in early September after eggs from Milo's Poultry Farms,

USA Today · 1d

FDA upgrades recall of eggs linked to salmonella to 'serious' health risks. Are there IN cases?

The recall was originally announced Sept. 6 by the Centers for Disease Control and Prevention. It was upgraded Sept. 30 to Class I.

Newsweek on MSN · 5h

Brownie Recall Update As FDA Sets Highest Risk Level

The brownies were found to contain an undeclared allergen, which can pose a serious risk to allergy sufferers.

The FDA is warning of serious health effects, possibly death, from a Wisconsin farm's eggs

A recall of eggs from a Wisconsin farm has been upgraded to "Class 1 status," meaning consumers may be at risk of serious ...

Were FDA's 'Black Box' Warnings on Antidepressants a Mistake? Youth Suicides Rose Afterwards

The FDA required that a Black Box warning be placed on antidepressants in 2005, notifying doctors of this possible effect in ...

STAT5h

Pharmalittle: We’re reading about compounders suing the FDA, Biogen turning to telehealth, and more

A trade group representing large compounding pharmacies sued the FDA over its removal of a widely prescribed Lilly diabetes ...

22hon MSN

FDA antidepressant warnings of suicide risk among kids may have the opposite effect, study finds

FDA black box warnings that antidepressants may be linked with suicidality among youth may have unintended, yet harmful, ...

1don MSN

FDA's promised guidelines on pulse oximeters unlikely to end decades of racial bias

For decades, widely used pulse oximeters have underestimated the oxygen needs of darker-skinned patients. Will the FDA's new ...

18hon MSN

US FDA approves Elanco's treatment for parasitic infections in dogs

The U.S. Food and Drug Administration has approved Elanco Animal Health's oral drug to protect dogs against six parasitic ...

1don MSN

Vegetable Recall Update: Warning for State As FDA Sets Highest Risk Level

The vegetable products were recalled due to a possible contamination with the bacteria Listeria monocytogenes.

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