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, ...

Sarepta Therapeutics ( NASDAQ: SRPT) faces an “arduous and treacherous path” to bring its gene therapy Elevidys back to market, according to a STAT report citing a senior FDA official, suggesting the ...

Sarepta stock fell after it agreed to voluntarily halt shipments of its experimental medicine Elevidys for Duchenne muscular ...

After the FDA request, Cambridge, Massachusetts-based Sarepta said in a statement that it will continue to ship the therapy to ambulatory people but maintain a halt it implemented June 15 for ...

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

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.

The Platform Technology Designation, which predates the current FDA leadership, is designed to streamline the drug development and review process, particularly for rare diseases.

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.