Drug approval is unequivocally the linchpin to any drug development effort and, given the role of the US market in the global ...

Confusion over the Food and Drug Administration’s delay in granting full approval to Novavax’s Covid ... of the company’s submission. In the process, Makary and a spokesman for the ...

Edwards Lifesciences has claimed a groundbreaking approval from the FDA that opens up its minimally invasive heart valve ...

Angela Buckalew has developed a prototype called CorConnect, a universal adapter designed to work with all seven major AED ...

FDA approved the Sapien 3 transcatheter aortic valve replacement (TAVR) platform for treatment of severe aortic stenosis ...

He said the company plans to price the drug so it’s accessible to a wide range of people. There are still unknowns about how the approval process will go, particularly in light of recent cuts at ...

We commend our team for driving this novel process from concept to approval with speed and capital efficiency, and we thank the FDA for its thorough and timely review as well as the Agency’s ...

Omniasecure, which was authorized for placement in the heart’s right ventricle, is the world’s smallest defibrillation lead, ...

William Blair analyst Brandon Vazquez said 2025 could be the first year market leader Intuitive Surgical will face meaningful ...

ADMA Biologics receives FDA approval for a process enhancing plasma production yields by 20%, boosting growth and capacity for its products. ADMA Biologics, Inc. has announced the U.S. FDA ...

(RTTNews) - ADMA Biologics, Inc. (ADMA) Monday said that the United States Food and Drug Administration (FDA) has approved the company's innovative production yield enhancement process. The ...