A PCR test detects the actual genetic material of the virus and involves a step that amplifies the presence of any material ...

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

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

On October 31, 2025, Anika submitted the third and final module of its Hyalofast PMA to the U.S. Food and Drug Administration (FDA). The PMA includes FastTRACK 24-month data and incorporates ...

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

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, ...

A long-running confirmatory trial of two of Sarepta Therapeutics’ Duchenne muscular dystrophy drugs has missed its main goal.

NV-CoV-2-R is our other drug candidate for COVID-19 that is made up of NV-387 with remdesivir encapsulated within its ...