The FDA launched a more accessible dashboard for its adverse event reporting system, the database that contains medication errors and product quality complaints, the agency said Sept. 28. The FDA ...

FDA recently announced the launch of a new searchable database containing almost 17,000 tobacco products that may be legally marketed in the U.S. The database provides information on each tobacco ...

An FDA database analysis shows that reported adverse skin events after GLP-1 receptor agonist use are rare but can include rash and pruritus, highlighting a need for further research, according to a ...

BALA CYNWYD, Pa., June 23, 2025 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (Larimar) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare ...

The FDA has launched a free mobile app version of its Drugs@FDA online database that offers consumers information on agency-approved drugs. The new app, called Drugs@FDA Express, is free and currently ...

A new tool about chemical contaminants in human and animal foods is available from the FDA. The Chemical Contaminants Transparency Tool is the latest effort by Health and Human Services Secretary ...

Larimar Therapeutics, Inc. has announced a refined timeline for submitting a Biologics License Application (BLA) for its treatment nomlabofusp, aimed at addressing Friedreich's Ataxia (FA). Based on ...

The FDA’s regular communications based on reports from its drug safety report database don’t always rattle investors’ cages. But that was not the case with a regulatory update Monday on argenx’s ...

The U.S. Food and Drug Administration and the National Library of Medicine have partnered to launch a portal making unique device identification information available to the public. In 2013, the FDA ...

FDA’s January 3, 2024, Federal Register notice soliciting comments on the agency’s plan to implement best practices for guidance development got me thinking. What do the data show regarding FDA’s ...

Interactions with FDA over the past year have provided clear expectations for the path to submission of the nomlabofusp BLA Written FDA recommendations for safety database include a total of at least ...