Vinay Prasad, a top regulator at the US Food and Drug Administration, has left the agency after a controversy over his ...

Sarepta Therapeutics’ stock was soaring Tuesday after the FDA recommended lifting the pause on the company’s Duchenne ...

I understand the heartbreak of watching someone you love spiral. But compassion cannot mean locking people up,” writes a STAT ...

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

Sarepta Therapeutics Inc. shares rose sharply early Tuesday after US regulators reversed course and recommended that patients ...

Over a whirlwind three weeks, Sarepta Therapeutics has faced tough safety questions around its commercial gene therapy ...

Wall Street had a slew of upgrades and downgrades from analysts. Here are some of the major calls for the week: J.P. Morgan ...

In the latest episode of STATus Report, Alex Hogan breaks down the confusing, heartbreaking saga of Sarepta and its gene ...

This regulatory relief, combined with several other compelling catalysts, creates a pathway for the stock to potentially ...

Monday, the FDA said Sarepta may resume treating ambulatory DMD patients with Elevidys. The recommendation comes just 10 days ...

The U.S. Food and Drug Administration said on Friday it was investigating the death of an eight-year-old boy who received ...

FDA probes Elevidys after an 8-year-old's death in Brazil; Sarepta and Roche say the death was unrelated to gene therapy ...