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FDA Official Who Halted Sarepta’s Gene Therapy Resigns Amid Backlash Over Access To Duchenne Treatment
Vinay Prasad has stepped down as head of the FDA’s biologics division just two months into the job, following growing ...
Just The News5h
FDA allows distribution of muscular dystrophy drug again after public criticism
The agency’s now-reversed decision to halt distribution of a gene therapy for children suffering from muscular dystrophy ...
FDA’s Vinay Prasad Exits After Sarepta Gene Therapy Controversy
Vinay Prasad, a top regulator at the US Food and Drug Administration, has left the agency after a controversy over his ...
Opinion
On Sarepta, a Welcome FDA Reversal
After our editorial, the agency relents to allow a Duchenne treatment.
Sarepta shares rebound after shipments of gene therapy Elevidys resume in US
Sarepta Therapeutics shares snapped a three-day losing streak on Tuesday, as analysts said resumption of U.S. shipments for ...
Sarepta Soars After FDA Says Some Patients Can Get Elevidys
Sarepta Therapeutics Inc. shares rose sharply early Tuesday after US regulators reversed course and recommended that patients ...
Sarepta's FDA woes raise questions for future of gene therapy treatments
Despite all the buzz around Sarepta and concerns about Elevidys, industry watchers aren’t convinced this current controversy ...