Tag Archives: FDA

Reuters reports: The U.S. Food and Drug Administration expanded approval for Johnson & Johnson’s nasal spray, Spravato, to allow it to be used as a standalone treatment for patients with severe depression, the company said on Tuesday. The ketamine-derived drug was first approved in 2019 to be used in combination with antidepressants, and later for patients experiencing suicidal thoughts or …

ABC News reports: Bags of ready-to-eat broccoli florets sold in 20 states have been recalled over concerns they may be contaminated with listeria. Braga Fresh Foods has voluntarily recalled one lot of its 12-ounce bags of Marketside Broccoli Florets, according to a recall notice shared by the U.S. Food and Drug Administration on Dec. 31. Braga Fresh Foods, a California-based …

USA Today reports: The Food and Drug Administration has classified a recall of eggs sold at Costco caused by potential salmonella contamination as the highest risk level for infection. The voluntary recall last month was of 108,000 cartons of Handsome Brook Farms eggs sold under the Kirkland Signature Organic Pasture Raised label. The FDA defines a Class I recall as …

Via press release from the FDA: Riverside Natural Foods Inc. is voluntarily recalling certain batches of MadeGood granola bars due to the potential presence of a piece of metal in the product, which, if consumed, may result in a safety hazard. The health and safety of our consumers is our highest priority. This recall is being initiated as a precautionary …

Politico reports: The raw milk brand favored by Robert F. Kennedy Jr. is facing a recall in California over safety concerns just as the CEO is poised to join the Trump administration at the behest of the former independent presidential candidate. Mark McAfee, CEO of Raw Farm, says he was asked by Kennedy’s running mate Nicole Shanahan to apply for …

CBS News reports: An Arizona produce company is recalling whole cucumbers distributed in 26 states and Canada because they could contain salmonella. In a filing posted by the Food and Drug Administration on Thursday, SunFed said the recalled cucumbers were sold between Oct. 12 and Nov. 26 and are being pulled from store shelves over possible contamination by the bacteria. …

Via press release from the FDA: Handsome Brook Farms is voluntarily recalling retail units of the Organic Pasture Raised 24-Count Eggs sold under the Kirkland Signature brand name because these eggs have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened …

The Hill reports: Yu Shang Food, Inc. is recalling more than 70,000 pounds of its ready-to-eat meat and poultry products because of a listeria outbreak that has sickened at least 11 people, including one baby who subsequently died. The U.S. Department of Agriculture’s Food Safety and Inspection Service said it discovered the problem on Oct. 21, 2024, during routine testing …

CBS News reports: President-elect Donald Trump nominated Dr. Marty Makary Friday to lead the Food and Drug Administration, selecting a surgeon and author who opposed vaccine mandates and some other public health measures during the coronavirus pandemic. Makary, a Johns Hopkins University professor, is the latest in a string of Trump nominees who have declared the U.S. health system to …

NBC News reports: About 167,000 pounds of both fresh and frozen ground beef products have been recalled over possible E. coli contamination, according to the the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS). After the Minnesota Departments of Agriculture and Health noticed a link between a group of reported illnesses and ground beef from Wolverine Packing Co., …

Axios reports: Public health efforts were weakened by misinformation and distrust during the COVID pandemic, but a brain drain of the nation’s top scientific minds could hobble research and dissolve institutional knowledge at agencies such as the Food and Drug Administration, National Institutes of Health and the Centers for Disease Control and Prevention. Less than a week after the election, …

Via press release from the FDA: Today, the U.S. Food and Drug Administration approved FluMist for self- or caregiver-administration. FluMist is approved for the prevention of influenza disease caused by influenza virus subtypes A and B in individuals 2 through 49 years of age. FluMist is sprayed into the nose and has been used safely and effectively for many years. …

Mashable reports: Apple’s newly announced hearing aid capability is officially the first over-the-counter (OTC) hearing aid software to be approved by the FDA. And it should be available on devices soon. The federal agency formally ushered in the tech giant’s new “Hearing Aid Feature” (or HAF, as the agency refers to it) mere days after the company’s keynote “Glowtime” event, …

Reuters reports: The U.S. Food and Drug Administration granted expanded approval to Emergent BioSolutions’ smallpox vaccine for use in people at high risk of mpox infection, sending the drugmaker’s shares 5% higher on Friday. The FDA clearance, announced late on Thursday by the company, makes the vaccine – called ACAM2000 – the second approved shot against mpox in the U.S. …

NBC News reports: The Food and Drug Administration on Thursday approved the new Covid vaccine from Pfizer and Moderna. It’s the third time the vaccines have been updated to match circulating strains since the original series. The shots should be available within days. The agency hasn’t yet approved a third vaccine, from drugmaker Novavax. The timing of the new vaccines …

NBC News reports: The Food and Drug Administration on Friday granted marketing authorization to the first at-home, over-the-counter test to detect syphilis antibodies in human blood in a move that could help boost screening rates for the sexually transmitted disease. Developed by privately held NOWDiagnostics, the antibody test helps identify current or past infection and provides a result in about …

NBC News reports: The Food and Drug Administration on Monday approved Guardant Health’s blood test, called Shield, to screen for colon cancer. The test isn’t meant to replace colonoscopies, but is generating enthusiasm among doctors who say it has the potential to boost the dismal rate of screenings for the second-highest cause of cancer death in the United States. Shield …

CNBC reports: The Food and Drug Administration on Tuesday approved Eli Lilly’s Alzheimer’s drug donanemab, expanding the limited treatment options for the mind-wasting disease in the U.S. The agency approved the treatment, which will be sold under the brand name Kisunla. Eli Lilly’s drug slowed Alzheimer’s progression by 35% over 18 months compared with a placebo, according to a late-stage …

The New York Times reports: A committee of independent advisers to the FDA voted unanimously on Monday that the benefits outweigh the risks of the newest experimental drug for Alzheimer’s disease. Alzheimer’s afflicts more than six million Americans. It has no cure, and there is no treatment or lifestyle modification that can restore memory loss or reverse cognitive decline. The …

NPR reports: A panel of experts advising the Food and Drug Administration on the use of the psychedelic MDMA for post-traumatic stress disorder found on Tuesday that the available evidence fails to show that the drug is effective or that its benefits outweigh its risks. It represents a major setback for proponents of the drug and its sponsor Lykos Therapeutics, …