Amid the upheaval, Grail continued to run studies to assess the ability of its Galleri blood test to detect a range of ...
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 ...
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 ...
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 ...
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.
Thermo Fisher Scientific Inc. (NYSE:TMO) is one of the most undervalued large cap stocks to buy according to analysts. On July 3, Thermo Fisher Scientific announced that its Oncomine Dx Express Test, ...
Starting today, Californians can order Teal Health’s FDA-approved cervical cancer screening test right to their homes. This represents an important step in making screening for cervical cancer more ...
Thermo Fisher Scientific’s Oncomine Dx Target Test Receives FDA Approval as a Companion Diagnostic to Identify Patients Eligible for Newest Targeted Therapy for Non-Small Cell Lung Cancer Test will ...
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 ...
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