Sarepta Therapeutics (SRPT) stock drops as the company faces potential FDA-mandated studies after safety concerns over its ...

Wall Street analysts warn that if Sarepta Therapeutics doesn't resolve the Elevidys issues, it could jeopardize its ability to repay debt in 2027.

The Food and Drug Administration won’t sign off on Sarepta Therapeutics Inc. bringing its controversial gene therapy back to ...

In this week’s edition of InnovationRx, we look at Moderna’s use of quantum computers, a new top drug regulator at the FDA, ...

The latest inspection comes 2 1/2 years after the agency allowed Sun Pharma to keep shipping some drugs to Americans even ...

The FDA is assessing the need for “further regulatory action” on Sarepta's Duchenne muscular dystrophy gene therapy in the aftermath of two patient deaths, though the regulator has not yet specified ...

Earlier on June 4, Sarepta Therapeutics announced that the US FDA has granted Platform Technology Designation to the rAAVrh74 viral vector.

With FDA platform technology designation for its viral vector, SRPT can fast-track other therapies using the same gene-delivery method.

CAMBRIDGE, Mass. - Sarepta Therapeutics, Inc. (NASDAQ:SRPT) announced that its rAAVrh74 viral vector, used in the investigational gene therapy SRP-9003 for limb-girdle muscular dystrophy type 2E ...

A report questions the FDA's accelerated approval process citing Sarepta and Biogen therapies as examples. Read more here.

Sarepta Therapeutics’ Duchenne muscular dystrophy gene therapy fell short of its main Phase 3 goal, but the firm contends the full body of evidence supports expanding the therapy’s label to ...