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The president overruled his HHS secretary and FDA chief, four people with knowledge of the decision tell POLITICO.
Dr. Vinay Prasad is stepping down as the Food and Drug Administration’s top vaccine regulator after a brief tenure. A ...
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The story of Sarepta's Duchenne gene therapy
The last couple of weeks has been particularly distressing for Duchenne muscular dystrophy patients and their families. The ...
Vinay Prasad, FDA's top vaccine official, has resigned after three months amid criticism and controversy, especially concerning the FDA's handling of a gene therapy for Duchenne muscular dystrophy.
Quantitative muscle ultrasound correlates strongly with ambulatory and timed function tests in Duchenne muscular dystrophy, ...
After our editorial, the agency relents to allow a Duchenne treatment.
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Shipments of Duchenne Gene Therapy to Resume After FDA Review of Patient Death
Sarepta's therapy has been under scrutiny from regulators after two teenage boys died earlier this year from acute liver ...
The FDA investigated the death of a boy in Brazil on Elevidys and concluded it was unrelated to the treatment.
Monday, the FDA said Sarepta may resume treating ambulatory DMD patients with Elevidys. The recommendation comes just 10 days ...
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