The FDA is set to request Sarepta Therapeutics to halt shipments of its gene therapy, Elevidys, after a third patient's death ...

Sarepta Therapeutics is pausing shipments of its gene therapy for muscular dystrophy following several patient deaths that ...

Sarepta has refused to suspend all dosing of its gene therapy for Duchenne muscular dystrophy, Elevidys, defying a clinical ...

Sarepta plummets after a third death in its muscular dystrophy program for investigational gene therapies, prompts FDA action and intensifies safety scrutiny.

A Massachusetts biotechnology company is laying off 21 employees in Durham amid a broader restructuring and pressure from federal regulators.

FDA may face scrutiny This latest incident casts a shadow over Elevidys, Sarepta’s flagship therapy, and may increase scrutiny of the U.S. Food and Drug Administration’s decision to approve ...

On Wednesday, HC Wainwright reiterated its Sell rating for Sarepta, maintaining a price forecast of $10.Analyst Mitchell Kapoor stated his belief that “it is highly likely that the FDA will at ...

On the 10-meter distance test, the drug was associated with a 0.42-second improvement versus placebo, Sarepta said. Related Most expensive drugs in the US in 2023 ...

Sarepta says more than 800 patients have received the treatment The company plans to update prescribing information after this case WEDNESDAY, March 19, 2025 (HealthDay News) -- A patient has died ...

Biotech firm Sarepta Therapeutics said that a second patient died after receiving its gene therapy to treat Duchenne muscular dystrophy, the latest drug to draw scrutiny after winning fast ...

Rather, Sarepta’s understanding is that the U-turn results from a reorganization at the FDA, the creation of the “super office” OTP—the Office of Therapeutic Products—and a desire to ...