Shares of Sarepta Therapeutics ($SRPT) jumped over 14% on Tuesday after the FDA authorized the company to restart shipments ...

The Food and Drug Administration’s polarizing vaccine chief is leaving the agency after a brief tenure that drew the ire of ...

George Tidmarsh has only been at the Center for Drug Evaluation and Research for nine days, but will now add supervision of a ...

The last couple of weeks has been particularly distressing for Duchenne muscular dystrophy patients and their families. The ...

After our editorial, the agency relents to allow a Duchenne treatment.

Sarepta Therapeutics shares snapped a three-day losing streak on Tuesday, as analysts said resumption of U.S. shipments for ...

Despite all the buzz around Sarepta and concerns about Elevidys, industry watchers aren’t convinced this current controversy ...

Shares of drugmaker Sarepta Therapeutics surged in afterhours trading Monday after the company said it would resume shipping ...

The FDA has lifted its hold on Elevidys for ambulatory patients, after asking Sarepta to pause the treatment following three ...

Sarepta Therapeutics has asked the Food and Drug Administration to approve its gene therapy for Duchenne muscular dystrophy under accelerated review, the company said Thursday. The biotechnology ...

CASE DETAILS: The filed complaint alleges that defendants made false statements and/or concealed that: (i) ELEVIDYS, a prescription gene therapy for Duchenne, posed significant safety risks to ...