Liquidating its stake in Arrowhead helps Sarepta cover a milestone payment and secure what one analyst described as ...

The stock has been in free fall since safety issues derailed a gene therapy analysts had expected to achieve blockbuster ...

A well-connected drug company and Laura Loomer wanted Kennedy ally Vinay Prasad gone. Trump Chief of Staff Susie Wiles got ...

Sarepta Therapeutics is selling off Arrowhead Pharmaceuticals’ shares to stretch its cash runway, while also inking a share ...

Jefferies analysts said these detailed safety outcomes confirm the gene therapy's positive risk/benefit profile in ambulatory ...

This episode of Pharma Pulse covers Vinay Prasad’s return to lead the FDA’s biologics center after a brief resignation, new ...

WASHINGTON, DC – Dr. Vinay Prasad has been reinstated to a senior position at the Food and Drug Administration, according to ...

Vinay Prasad is once again head of the FDA’s Center for Biologics Evaluation and Research, after Laura Loomer led a campaign ...

Some oncologists and researchers have raised concerns about delays in the completion of confirmatory trials, but FDA now has new tools to push them ahead.

Sarepta Therapeutics said Friday that the deaths of two patients taking its marketed gene therapy Elevidys® (delandistrogene ...

The Food and Drug Administration (FDA) is hitting some speed bumps in implementing the Trump campaign agenda, and the ...

Vinay Prasad, a top vaccine regulator ousted from the Food and Drug Administration (FDA) late last month, is set to return to his post, according to the Department of Health and Human Services ...