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.

"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.

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

“We are pleased that Tower 28 has received the NRS Seal of Acceptance for its latest collection of ... The cleanser is also clinically tested and approved by dermatologists. — SOS Recovery Cream. This ...

The US State Department has approved the sale of precision-guided weapon systems to Saudi Arabia, according to the Pentagon, marking the latest US-Saudi arms deal under President Donald Trump.