A long-running confirmatory trial of two of Sarepta Therapeutics’ Duchenne muscular dystrophy drugs has missed its main goal.
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, ...
The agency will no longer require studies comparing copycat biologics to their branded counterparts, which could help ...
The Simplexa COVID-19/Flu A/B & RSV Direct Kit is used for the detection and differentiation of infections with SARS-CoV-2, flu A/B, and respiratory syncytial viruses.
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