Federal Register notice: FDA announces a 10/7 Antimicrobial Drugs Advisory Committee meeting to discuss Takeda's maribivir.
Federal Register notice: FDA sends to OMB an information collection extension entitled Request for Samples and Protocols.
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Federal Register notice: FDA determines that Bausch Health Americas Efudex (fluorouracil) topical solution, 5%, was not withdrawn from sale for reason...