The Latest Breaking News from FDA

On Thursday, Telix Pharmaceuticals Limited (NASDAQ:TLX) received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the Biologics License Application (BLA) for TLX250-CDx (Zircaix, 89Zr-DFO girentuximab), an investigational PET2 agent for the diagnosis and characterization of renal masses as clear cell renal cell carcinoma (ccRCC).

We want to hear people’s views about the change making only those 65 and up automatically eligible for the vaccines

A panel convened in July 2025 by the Food and Drug Administration sparked controversy by casting doubt about the safety of commonly used antidepressants during pregnancy. But it also raised the broader issue of how little is known about the safety of many medications used in pregnancy, considering the implications…

Antonio Gracias is part of the growing movement among Silicon Valley’s right wing enamored with the therapeutic and commercial potential of drugs like MDMA

Susan Monarez, confirmed as Centers for Disease Control and Prevention director in July 2025, refused to resign on Wednesday after reports of her removal sparked a major public health controversy.

Guidance around COVID-19 vaccines has once again shifted after the Food and Drug Administration on Aug. 27, 2025, approved updated shots for the fall season, but for a more limited group than in prior seasons.

Health and Human Services Secretary Robert F. Kennedy Jr. announced on social media that the emergency use authorizations for COVID-19 vaccines have now been rescinded.

It depends on your age, insurance coverage, health and finding a health care professional who will give you the shot

Agency authorizes shots for those 65 and older, with young people eligible if they have underlying medical conditions