The Revell family hoped a gene therapy could buy time for their sons, who have a rare and fatal disease. After two patients died, the drug’s manufacturer halted dosing under pressure from the FDA.

Sarepta Therapeutics' brutal week continued Friday after European officials rejected the company's controversial gene therapy ...

Sarepta Therapeutics Inc. shares plunged after European regulators rejected its gene therapy Elevidys, intensifying scrutiny on the drugmaker after it was pressured to halt shipments of its treatment ...

European regulators on Friday said that the Duchenne muscular dystrophy gene therapy Elevidys should not be approved ...

A timeline of key developments surrounding Sarepta Therapeutics' Duchenne muscular dystrophy drug Elevidys, and the potential ...

Sarepta Therapeutics (SRPT) stock is back in focus as Roche (RHHBF) pauses global shipments of its Elevidys gene therapy ...

Analysts questioned whether the complete response letter Replimune received was evidence of changing approval standards at the FDA.

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

Medicaid and ACA, the homeless crisis, children's health, 'black box' drug warnings, nutrition and SNAP, maternity care, and more.

Sarepta's pause on its prescription gene therapy drug for Duchenne muscular dystrophy gives the company time to work with the FDA on reviews. Infusions nationwide will be canceled. Also in the news, ...

After initially refusing to suspend Elevidys distribution after two deaths, Sarepta has now given in to the FDA’s request, ...

Sarepta will halt all shipments of Elevidys, its drug for Duchenne muscular dystrophy patients, by Tuesday evening.