To meet the requirements for FDA Breakthrough Device Designation, CDx Diagnostics submitted technical and clinical evidence ...

The European Union’s health regulatory agency did not endorse approving Elevidys for ambulatory patients with Duchenne ...

The strategic reprioritization comes after the company hit two major hurdles in the past year, including a clinical hold for ...

CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an ...