FDA clears Coronary Systems 1.00mm Sapphire coronary balloon.
Opposed by womens health advocacy group National Center for Health Research, medical device industrys AdvaMed supports a CDRH and CBER proposal on a V...
FDA issues a safety alert about unapproved products claiming to prevent, treat or cure influenza.
Biogen and AbbVie announce the worldwide withdrawal of Zinbryta (daclizumab)for relapsing multiple sclerosis due to safety concerns.
President Donald Trump says the federal government will bring lawsuits against pharmaceutical companies that may have used false, deceptive or unfair ...
FDA clears an Alfa Scientific Designs 510(k) for its Simple Cup multi-drug test with Driven Flow, a multi-drug of abuse urine test.
CBER researchers say they are closer to understanding how to accurately interpret studies using microfluidics platforms so they can support developmen...
Federal Register notice: FDA reopens a docket for public comment on the susceptibility test interpretive criteria for antibacterial and antifungal dru...