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

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 ...

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

Welcome back to Changing Faces, in our final round-up for August and September there are plenty of Board appointments to ...

Sarepta said on Monday that its late-stage study testing two gene-targeted therapies for Duchenne muscular dystrophy did not meet the main goal, sending its shares plummeting over 37% in extended ...

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.

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, ...

A wave of the highly contagious respiratory syncytial virus is beginning to wash over the United States, sending greater numbers of babies and toddlers to the hospital for professional care.

The Federal Aviation Administration announced Wednesday that it will reduce air traffic by 10% across 40 “high-volume” markets beginning Friday morning to maintain safety during the ...