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 ...

The U.S. FDA is planning to require all new vaccines to undergo placebo-controlled trials before approval. Read more here.

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

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

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 ...

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 ...

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

Edwards Lifesciences has claimed a groundbreaking approval from the FDA that opens up its minimally invasive heart valve implants to patients before they begin to show cardiac symptoms.

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 ...

The US Food and Drug Administration (FDA) has granted approval for the use of Medtronic’s disposable ... sensor for MiniMed ...