FDA revises Regenerons emergency use authorization for Regen-Cov (casirivimab and imdevimab), expanding its emergency use as post-exposure prevention ...
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Federal Register notice: FDA determines that Bausch Health Americas Efudex (fluorouracil) topical solution, 5%, was not withdrawn from sale for reason...
Federal Register notice: FDA makes available a draft guidance entitled Rabies: Developing Monoclonal Antibody Cocktails for the Passive Immunization C...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.