Keeping Track: Vascepa Adds CV Risk Reduction Claim And Submissions Pour Into FDA

Here's your US review and submission news in brief: The Vyondys 53 (golodirsen) saga took a surprising turn last week, as its sponsor Sarepta Therapeutics Inc.scored an approval for the Duchenne muscular dystrophy (DMD) drug from the US Food and Drug Administration after quietly appealing the complete response letter (CRL) from four months earlier.