Sarepta Therapeutics faces an "arduous path” to try to get its gene therapy for Duchenne muscular dystrophy back onto the market, a senior FDA official told STAT.

Sarepta will halt all shipments of Elevidys, its drug for Duchenne muscular dystrophy patients, by Tuesday evening.

The FDA on Tuesday rejected a skin therapy from Replimune Group, suggesting a hardened stance on drug approvals under new agency officials ...

The FDA will request Sarepta Therapeutics stop all shipments of Elevidys, its gene therapy for Duchenne muscular dystrophy, ...

Sarepta Therapeutics announced it has laid off more than one-third of its workforce, a drastic cost-cutting move following ...

Next month will be the first opportunity to gauge the commercial launch of a new treatment for Prader-Willi syndrome, a rare ...

Just how many employees is Sarepta Therapeutics laying off? And why did the FDA reject Ultragenyx's rare disease drug over ...

On this week's episode of "The Readout LOUD": a closer look at the NIH’s grant-cutting legal playbook, FDA transparency ...

The FDA rejected a Duchenne muscular dystrophy cell therapy from Capricor Therapeutics, as a larger study of the treatment ...

Merck said it will buy Verona Pharma for $10 billion to bolster its lung-disease business and help replace the expected loss ...

Feuerstein, 48, grew up on Long Island, N.Y., and majored in political science at Emory University. He got his start in professional journalism while still in college, doing a six-month internship ...

Adam Feuerstein: Powers claims the company's cancer immunotherapy DCVax [ sic, DCVax-L] demonstrated a large and statistically significant survival benefit in a couple of phase I brain tumor ...