FDA dismisses concerns raised in a JAMA Internal Medicine report that many medical device adverse event reports involving a patient death are misclass...
FDA clears a TransMedics Group 510(k) for its OCS Lung Solution for use in transplants using cold storage techniques.
FDA approves GlaxoSmithKlines Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5, as a treatment for patients with chronic rhinosi...
Federal Register notice: CDER and CBER announce the effective date of 9/15 for using Electronic Common Technical Document validations referenced in FD...
Federal Register notice: FDA determines that Bausch Health Americas Efudex (fluorouracil) topical solution, 5%, was not withdrawn from sale for reason...
Federal Register notice: FDA makes available a draft guidance entitled Rabies: Developing Monoclonal Antibody Cocktails for the Passive Immunization C...
A bipartisan group of four senators asks HHS to pursue policies to allow Americans to import some drugs from Canada.
Washington Legal Foundations asks the 1st Circuit Court of Appeals to reverse the conviction of two former medical device executives for distributing ...