Learn more about whether ADMA Biologics, Inc. or Sarepta Therapeutics, Inc. is a better investment based on AAII's A+ ...

The biotech, which cut jobs following the rejection in May of its Barth syndrome therapy, claimed it has addressed the agency ...

Sarepta Therapeutics has provided additional safety data on its gene therapy Elevidys as a Duchenne muscular dystrophy ...

Some experts worry that patient groups’ growing influence is leading to the approval of drugs that may not work and could ...

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 ...

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.