"It would not be surprising if we saw longer review times, at least in the near term," Shuren said about the FDA layoffs.

Vivex Biologics chairman John McCallum breaks down the challenges, costs, and strategies behind bringing medical innovations ...

Gore & Associates recently announced an expansion of the Gore TAG conformable thoracic stent graft with Active Control system ...

The agency is sitting on a decision to grant full approval for Novavax’s shot, days after top vaccine regulator pushed out.

Folks with cancer that has gene variants or rare diseases often need laboratory-developed tests for information that could ...

Amid a dramatic reshaping of the federal healthcare apparatus, the FDA has named an acting leader of its Center for Biologics Evaluation and Research. | Amid a dramatic reshaping of the federal ...

A little over a year after winning manufacturing certification for its cell therapy factory-in-a-box, South San Francisco’s ...