Over a whirlwind three weeks, Sarepta Therapeutics has faced tough safety questions around its commercial gene therapy ...

Vinay Prasad’s ouster as the Food and Drug Administration’s top vaccine and gene therapy regulator came after frustration ...

Niemann-Pick Disease Type C (NPC) is a rare genetic disorder caused by mutations in the NPC1 or NPC2 genes, leading to harmful lipid accumulation in organs like the liver and brain. Symptoms, often ...

This week on "The Readout LOUD," STAT's biotech reporters parse what Vinay Prasad's ouster means for biotech and the FDA.

OH and the leaf of the kratom plant are not analogous, but as the former is a derivative of the latter, it has opioid-like qualities that make its susceptibility to abuse concerning.

The U.S. Food and Drug Administration's (FDA) top vaccine official is stepping down after just three months in a role that ...

Shipment of delandistrogene moxeparvovec, a gene therapy for Duchenne muscular dystrophy (DMD), will resume following a ...

Indian-origin scientist Vinay Prasad resigned as the FDA's vaccine and gene therapy chief in just three months after backlash ...

But this time, the unknown is hitting the industry in a different way from when Prasad was tapped to lead CBER less than ...

Gene Therapy Market Gene therapy market surges on breakthroughs in genome editing, rising chronic & genetic disease cases, regulatory appro ...

Other changes under Prasad, who was also the agency's chief medical and science officer, included a new policy limiting the ...

Dr Vinay Prasad has resigned from the FDA after less than three months amid controversy over Sarepta Therapeutics' gene ...