The FDA is still on track to meet its user fee targets despite a higher-than-normal vacancy rate among scientific reviewers.

Sarepta Therapeutics failed to win the European drug regulator's backing for its muscle disorder gene therapy on Friday, as ...

The European drug authority recommends refusal of marketing authorization after study shows no benefit over placebo.

Complete Response Letters recently issued by the FDA signal heightened scrutiny of trial design and reinforce the agency’s shifting regulatory expectations for sponsors and CROs.

Sarepta has suffered another regulatory setback after the European Medicines Agency’s (EMA’s) Committee for Medicinal ...