Alzheimer’s disease’s first in vitro diagnostic test was granted to Breakthrough Device Designation. The U.S. Food and Drug Administration approved its marketing. The amyloid plaques early detection diagnostic test called Lumipulse G β-Amyloid Ratio (1-42/1-40) is ideal for patients aged 55 years and older displaying cognitive impairment and other causalities of cognitive decline. Dr. Jeff […]
A U.S. Food and Drug Administration (FDA) safety communication warns people not to use the COVID-19 Direct Antigen Rapid Test distributed by E25Bio as it is not authorized, cleared, or approved by the agency due to lack of transparency by the company. As a result, its distribution or use in the United States is not […]
The Centers for Disease Control (CDC) advisory panel have recommended that people should not get the Johnson & Johnson (J&J) COVID-19 vaccine if the Moderna and Pfizer-BioNTech shots are available. The Advisory Committee on Immunization Practices announced its recommendations after the Food and Drug Administration (FDA) said the J&J vaccine has been linked to a […]