News

FDA’s Reversal on Gene Therapy Helps My Son
Parents of boys with Duchenne muscular dystrophy weigh in on drug innovation and medical regulation.
Fierce Pharma2d
Vinay Prasad departs FDA amid conservative criticism, controversy over Sarepta gene therapy
Vinay Prasad, M.D., has left the FDA less than three months into the role as director of the Center for Biologics Evaluation ...
Just The News3d
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 ...
News Nation on MSN4d
Parents urge FDA to restore gene therapy after distribution pause
A recent FDA investigation has paused further distribution of Elevidys, following reports of at least three patient deaths.
Fierce Pharma1d
Vinay Prasad's exit signals FDA's probable slip toward more permissive regulation of cell and gene therapy: analyst
But this time, the unknown is hitting the industry in a different way from when Prasad was tapped to lead CBER less than ...
STAT3d
Pharmalittle: We’re reading about a new Novo Nordisk CEO, an FDA reversal on Sarepta, and more
Novo Nordisk tapped Maziar Mike Doustdar, its head of international operations, as its new chief executive officer and ...