The FDA posted its warning letters on December 12, naming Walmart, Target, Kroger, and Albertsons for failing to quickly remove ByHeart infant formula from sale after its recall on November 14. On November 20, Newsweek reported the botulism outbreak had affected 31 babies across 15 countries.

Former US public health officials are sounding alarms about significant changes being made to the country’s vaccine policy under the Trump administration.

The U.S. Food and Drug Administration (FDA) is considering adding the strongest safety warning available to COVID-19 vaccines.

As regulatory uncertainty around COVID vaccines continues to swirl, a new report from the Centers for Disease Control and Prevention (CDC) showcases the benefits of the immunizations among children | The CDC findings were released as the FDA considers placing a black box safety warning on COVID vaccines,

The 2024–2025 formulations of COVID-19 vaccines had an effectiveness rate of 76% at preventing emergency or urgent care visits in children aged 9 months through four years, according to a new report.

The Food and Drug Administration has launched a safety review of two approved RSV drugs for infants, the latest immunizations to face scrutiny under Health Secretary Robert F. Kennedy Jr.

Dr. Tracy Beth Høeg, a sports medicine physician and epidemiologist, will lead the FDA office that oversees the safety and effectiveness of prescription and over-the-counter drugs and approves new medicines.