The agency might dissuade patients from participating in a crucial part of our research-and-development system.

The U.S. FDA approved a pricey rare disease drug in September despite findings by its data reviewers that the treatment, ...

New diagnostic kits aim to revolutionize early screening of the disease, potentially allowing patients to receive treatments—such as monoclonal antibodies—sooner.

Augurex’s Spinestat diagnostic test earned the FDA’s breakthrough device designation. Spinestate is a 14-3-3eta autoantibody multiplex immunoassay test for diagnosing axial spondyloarthritis, ...