Two companies now hold federal clearance to sell chicken grown from animal cells in the United States, yet consumers in at ...
Wildtype’s cell-cultivated salmon has received FDA approval, marking the first time lab-grown fish has been deemed safe to eat in the United States. Kann, a critically acclaimed Haitian restaurant in ...
Diazyme Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Diazyme Lipoprotein(a) Molarity Assay. This clearance enables clinical ...
Trained Scientists, Biotech Startup Advances Predictive AI to Improve Human Safety Assessment, Reduce Costly Drug Attrition and Accelerate Drug Development BOSTON, MA / ACCESS Newswire / July 7, 2026 ...
The US Food and Drug Administration (FDA) plans to hold a meeting to collect public feedback on a controversial proposal to revoke a longstanding regulatory exemption for lab-developed tests (LDTs) ...
The US Government Accounting Office (GAO) found that many elements of an effort to improve laboratory safety at the Food and Drug Administration (FDA) have not been met, over three years after ...
The US Food and Drug Administration (FDA) plans to scrutinize the safety and efficacy of lab-developed tests — those designed, manufactured, and used in a single laboratory — far more thoroughly in ...
On April 29, 2024, the Food and Drug Administration (FDA) announced a final rule to consider laboratory-developed tests (LDTs) to be medical devices and thus under FDA oversight. 1 LDTs are laboratory ...
Lizzy leads STAT’s coverage of the FDA. Her stories explore the relationship between politics and science at the FDA, industry influence, and the agency’s ability to protect and promote public health.