U.S. regulators asked Sarepta Therapeutics on Friday to voluntarily halt shipments of its Elevidys gene therapy after a ...

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 ...

Key Points Sarepta Therapeutics' most crucial product is turning out to have severe safety issues. The company's efforts to improve its situation were well received, but this victory didn't last long.

Second-quarter earnings come amid many high-level challenges for the biopharma industry. How will these five closely watched ...

Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced a strategic restructuring plan ...

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

A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli ...

The company said it was “surprised” by the decision, which followed the ouster of cell and gene therapy officials from the ...

Del-zota is designed for patients with mutations amenable to exon 44 skipping, which is just 7% of the overall DMD patient ...

As Domnick explains, the situation reflects broader systemic issues—particularly around how the FDA handles fast-track approvals and whether families are truly informed of the risks. "These are ...