FDA grants Bio-Techne a breakthrough device designation for its ExoDx Prostate IntelliScore test, which the company says is the first exosome-based li...
Federal Register notice: FDA requests that any industry organizations interested in participating in selecting nonvoting industry representative to se...
FDA approves Cochlear Limiteds new Cochlear Nucleus Profile Plus Series Cochlear Implant and the Nucleus 7 Sound Processors new built-in connectivity ...
FDA grants NuCana an orphan drug designation for its investigational drug, Acelarin (NUC-1031), and its use in treating biliary tract cancer.
Department of Homeland Securitys National Cybersecurity and Communications Integration Center issues a cybersecurity alert on BDs Alaris Gateway Works...
A just-posted article in BMC Medicine finds that about half of studies FDA requires in post-marketing commitments are ever published in peer-reviewed ...
FDA Review posts the Federal Register notices for the week ending 6/14/2019.
FDA releases its latest batch of Warning Letters that includes Advanced Botanical Consulting and Testing, Spectrum Laboratory Products and Vida Intern...