Sarepta Therapeutics Inc. shares rose sharply early Tuesday after US regulators reversed course and recommended that patients who can walk be allowed to take its gene therapy Elevidys again.

Roche Holding AG said on Tuesday it has paused shipments of muscular disorder gene therapy Elevidys in some countries outside the U.S., echoing a similar decision by U.S. partner Sarepta Therapeutics ...

Sarepta Therapeutics Inc.’s shares soared after the US biotech reported revenue that beat estimates, which analysts ...

The U.S. Food and Drug Administration said on Friday it was investigating the death of an eight-year-old boy who received Sarepta Therapeutics' muscular disorder gene therapy Elevidys. The death ...

The Food and Drug Administration won’t sign off on Sarepta Therapeutics Inc. bringing its controversial gene therapy back to the market until the company can persuade US regulators that it won’t cause ...

The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...

Sarepta Therapeutics said on Monday it will resume shipping of its muscular disorder gene therapy to patients who can walk, sending the company's shares 59% higher in extended trading.

Parents of boys with Duchenne muscular dystrophy weigh in on drug innovation and medical regulation.