The MosaiQ AiPlex CD is designed to improve the  accuracy and speed of celiac disease diagnosis while simplifying laboratory workflows EYSINS, Switzerland , Feb.

On December 27, 2024, the US Food and Drug Administration (FDA) published its final rule to update the definition for “healthy” claims on food ...

Biodexa Receives US FDA Fast Track Designation for eRapa in Familial Adenomatous PolyposisUnderscores unmet need for a ...

The Fast Track designation accelerates troculeucel’s path to U.S. FDA submission for the treatment of patients with moderate Alzheimer’s ...

Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems. The FDA has issued warning ...

The agency updates and modifies the alerts as needed. Recent modifications to FDA’s import alerts, as posted by the agency, are listed below. Click here to go to the FDA page with links to ...

vaccine has recently been submitted for clinical trials to the U.S. Food and Drug Administration (FDA). The vaccine has demonstrated significantly higher humoral and cellular immunity compared to ...

Many consumer devices undergo the FDA clearance process, such as LED masks and fitness trackers that have features like ...

Biodexa has received US FDA Orphan Drug designation for eRapa in FAP and plans to seek a similar designation in Europe.

The Trump administration had directed health agencies to place a notice condemning “gender ideology” on health webpages that ...

A federal judge has ordered the US Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) to restore access to public health websites that were removed or modified in ...

Reports of impending layoffs, a buyout offer, and a return-to-office mandate have put a damper on FDA staff morale ...