#FDA

#FDA

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.

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.

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.

"Please stop harming women," she said, emphasizing the dangers associated with the FDA's black box warning labels on hormone replacement therapies. The warnings deter women from beneficial treatments.

"Anything that you don't have time to double-check is unreliable. It hallucinates confidently."

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.

"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.