The FDA said it was clearing the way for Sarepta Therapeutics to resume shipments of its gene therapy for Duchenne muscular dystrophy to some patients.

Vinay Prasad has stepped down as head of the FDA’s biologics division just two months into the job, following growing backlash over how he handled Sarepta’s Elevidys, the only approved gene therapy for Duchenne muscular dystrophy.

Sarepta's therapy has been under scrutiny from regulators after two teenage boys died earlier this year from acute liver injury, a known side effect of the treatment. The FDA then requested a pause in shipments of the drug after the death of a third patient taking a different Sarepta therapy.