PTC Therapeutics faces pivotal FDA decisions for approvals that could potentially transform their long-term revenues. Click ...

The U.S. Food and Drug Administration's (FDA) top vaccine official is stepping down after just three months in a role that ...

Shipment of delandistrogene moxeparvovec, a gene therapy for Duchenne muscular dystrophy (DMD), will resume following a ...

But this time, the unknown is hitting the industry in a different way from when Prasad was tapped to lead CBER less than ...

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

Dr. Vinay Prasad is stepping down as the Food and Drug Administration’s top vaccine regulator after a brief tenure. A ...

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 ...