The U.S. Food and Drug Administration (FDA) plans to rescind its laboratory developed test (LDT) rule dated May 6, 2024. The rule would have regulated LDTs as in vitro diagnostic products (IVDs) and ...
New options for testing and treating some of the most common sexually transmitted diseases are becoming available.
The Food and Drug Administration’s recent approval of a new blood test to aid in the diagnosis of Alzheimer’s disease is a boost for the School of Nursing’s wet lab. The lab, led by nursing researcher ...
A new way to screen for colon cancer is giving Americans more options to spot the disease in its early stages. According to the American Cancer Society, 1-in-3 adults do not get screened as ...
WASHINGTON — 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 ...
FDA’s Authority Over Lab-Developed Tests Overturned: What the Court’s Decision Means for Lab Testing
Previously, this blog covered the FDA’s decision to regulate lab-developed tests (LDTs) as medical devices. However, a ruling from a federal district court in Texas earlier this year has changed that.
Swiss-based Roche announced this month that it has received U.S. regulatory clearance for a less-complex vitamin D test in the United States, which the company said opens the door to more efficient ...
Guardant360 CDx is approved to identify ESR1 mutations in advanced breast cancer, aiding treatment with Inluriyo. Inluriyo showed a 38% lower risk of disease progression in the EMBER-3 trial compared ...
The FDA has approved bioLytical Laboratories’ Insti HIV self test. The company touts it as the fastest home-use HIV test available in the U.S., with results in 60 seconds or less. BioLytical said the ...
In May 2025, the FDA approved mepolizumab (Nucala) as a treatment for chronic obstructive pulmonary disease (COPD). Before any drug gets near a pharmacy shelf, it starts with years of basic science ...
The FDA in April 2025 approved nipocalimab (Imaavy) as a treatment for people living with generalized myasthenia gravis (gMG). Specifically, nipocalimab is for people with gMG who are 12 and older and ...
BUFFALO, N.Y. – The Food and Drug Administration’s recent approval of a new blood test to aid in the diagnosis of Alzheimer’s disease is a boost for the University at Buffalo School of Nursing’s wet ...
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