#fda

#fda

On Friday, Vinay Prasad-the Food and Drug Administration's chief medical and scientific officer and its top vaccine regulator-emailed a stunning memo to staff that quickly leaked to the press. Without evidence, Prasad claimed COVID-19 vaccines have killed 10 children in the US, and, as such, he announced unilateral, sweeping changes to the way the agency regulates and approves vaccines, including seasonal flu shots.

As of Wednesday, the Food and Drug Administration (FDA) said, 31 cases of suspected or confirmed infant botulism have been reported in babies who consumed ByHeart Whole Nutrition formula and got sick between August and mid-November. No deaths have been reported. But all 31 babies were hospitalized with the illness, which can cause a potentially life-threatening form of gradual paralysis in infants less than a year old.

In September, Tidmarsh went after Tang's Aurinia and its drug voclosporin that treats lupus nephritis, a disease in which the immune system attacks the kidneys. In a startling post on his LinkedIn account, Tidmarsh claimed that the FDA-approved drug had not been shown to provide "hard" clinical benefit and that the drugmaker had not performed necessary trials. Such a post from the FDA's top drugmaker turned heads.

Oura Health Oy, the Finnish smart ring maker, is the latest wearable company seeking to move into blood pressure monitoring. On Monday, the startup said it plans to launch a Blood Pressure Profile study later this year, designed to detect early signs of hypertension or elevated blood pressure without displaying actual systolic or diastolic readings, as part of efforts to develop a future consumer feature. The study will track users' data without a traditional cuff and provide information to help users better understand their potential risk levels.

The FDA has issued another recall notice, expanding the list of products that could be contaminated with Cs-137. This recall is being carried out by Aqua Star (USA) Corp. of Seattle. As with previous recalls, these shrimp were processed by an Indonesian company whose containers tested positive for Cs-137. Cs-137 is a radioactive isotope that is widely found in trace amounts throughout the environment, due to widespread testing of nuclear weapons in the 1950s and 1960s.

The U.S. Food and Drug Administration (FDA) has published a recall notice on its website warning of potential Listeria monocytogenes in several cheese products. The FDA's warning was published on September 8, three days after the Ohio-based company behind the cheese announced the recall. That company is Middlefield Original Cheese Co-op, which produces multiple cheese products. Middlefield initiated the recall after detecting Listeria monocytogenes in some of its finished products as well as on cutting equipment surfaces.

According to a press release from the Food and Drug Administration, a shipment of frozen shrimp from BMS Foods, an Indonesian supplier, tested positive at customs for Cesium-137, a radioactive isotope.

Pfizer's Covid vaccine for young children may not be renewed by the FDA this fall, leading to a gap in available vaccines for those under five.

The Fourth Circuit Court of Appeals upheld West Virginia's law banning FDA-approved medication abortion, marking the first federal court to sanction such a ban and undermining the FDA's regulatory authority.

The recall includes three separate products: the Power Stick For Her Roll-On Antiperspirant Deodorant, Power Stick Invisible Protection Roll-On Antiperspirant Deodorant, and Power Stick Original Nourishing Invisible Protection Roll-On Antiperspirant Deodorant.

Trump's decision to pause NIH grant-making for over two months halted approximately $1.5 billion in funding, disrupting clinical trials for new cancer drugs and research.

The Food and Drug Administration has issued several mushroom-related recall notices after testing revealed Listeria monocytogenes, which poses serious health risks, particularly to vulnerable groups.

The FDA's updated warning indicates a 'reasonable probability' of serious health harms or death from potentially contaminated blueberries linked to Listeria.

"Hims & Hers engaged in deceptive promotion and selling of illegitimate, knockoff versions of Wegovy that put patient safety at risk."

Sun Pharma's factory faced severe scrutiny after inspectors found contamination, leading to a ban on exportation to the U.S., highlighting the conflict between safety and drug supply.

In a bid to enhance transparency, the FDA has proposed a black-box warning for breast implant packaging, underscoring the serious risks associated with their use.