CardioVia’s ViaOne device helps treat cardiac arrhythmias, replacing conventional exposed needle methods that risk puncturing ...

CardioVia announced today that it received FDA clearance for its minimally invasive ViaOne epicardial access system.

VitaSeal offers a 90-day money-back guarantee. If you are not satisfied with the product, you can return it-even empty ...

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

Amgen (NASDAQ: NASDAQ:AMGN) announced that the U.S. Food and Drug Administration (FDA) has granted an expanded label approval ...

The U.S. Food and Drug Administration has approved expanded use of Amgen's drug, Uplizna, to help reduce the risk of flares in patients with a rare immune system-related condition, the regulator said ...

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 ...

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