The first blood plasma test to identify hallmarks of Alzheimer’s disease was cleared in May by the U.S. Food and Drug Administration (FDA), and University of Wisconsin researchers provided a portion of the samples used in the clinical validation test....
The US Food and Drug Administration has given clearance to another blood test to help assess Alzheimer’s disease and other causes of cognitive decline, providing a broader understanding of when the disease can be ruled out....
On October 15, 2025, the CITI Program will update the modules in UW–Madison’s Good Clinical Practice for Drug/Device Researchers and Refresher courses to reflect the ICH E6(R3) guidelines...
Leveraging artificial intelligence could help drug developers more efficiently screen chemical libraries to identify the few chemicals most likely to affect their research targets....
As one efficacy guideline among others created by the ICH, E6(R3) is more than just a technical update. It represents a paradigm shift in how clinical trials are designed, conducted, and overseen....
Insmed’s Brinsupri is the first drug specifically approved for treating non-cystic fibrosis bronchiectasis, a progressive and potentially fatal lung disorder. The drug, licensed from AstraZeneca, inhibits activation of neutrophils, white blood cells that play a role in inflammatory and immune responses....
Lenacapavir nearly eliminated new infections in wide range of patients in phase III studies....
In an article recently published by The New England Journal of Medicine, FDA higher-ups Vinay Prasad, MD, MPH; and Martin A. Makary, MD, MPH, wrote that any new COVID-19 vaccine must now be evaluated in placebo-controlled studies....
U.S. health officials on Friday endorsed the first blood test that can help diagnose Alzheimer’s and identify patients who may benefit from drugs that can modestly slow the memory-destroying disease....
The US Food and Drug Administration has approved the first at-home self-collection device for cervical cancer screening in the United States, called the Teal Wand, according to the women’s health company Teal Health....
