As gene therapy maker Sarepta Therapeutics tangles with FDA over its Duchenne treatment, patients and their families are ...

Sarepta stock plunged again Thursday on a report the FDA will require additional clinical testing to validate the safety ...

This week on "The Readout LOUD" podcast, a mother whose son has Duchenne muscular dystrophy shares her perspective on Sarepta ...

Sarepta would need to conduct new analyses to validate the safety of Elevidys—which has had U.S. shipments paused by the ...

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

Shipments will halt by close of business Tuesday evening, the company said. Sarepta had initially rejected the agency’s ...

The family of a seven-year-old boy diagnosed with a life-changing condition are raising funds to build a specially-adapted ...

Roche is pausing shipments of Elevidys in some countries, following partner Sarepta Therapeutics’ move in the U.S., as safety ...

There were warnings to the FDA about Sarepta Therapeutics Inc. before US regulators asked the company to halt shipments of its gene therapy.

Sarepta rebuffed a call from the Food and Drug Administration to halt all shipments of its gene therapy for Duchenne muscular ...

A 15-year-old boy in New Market with a neuromuscular disorder received a wheelchair accessible van last week through the ...

Duchenne muscular dystrophy (DMD) is a severe neuromuscular genetic disease characterised by progressive muscle weakness and degeneration and is the most common type of muscular dystrophy globally.