New data from the pivotal Phase 3 KEYNOTE-091 trial finds that adjuvant treatment with Mercks Keytruda significantly improved disease-free survival, r...
Federal Register notice: FDA revokes an Emergency Use Authorization issued to Abbott Diagnostics Scarborough for the BinaxNOW Covid-19 Ag Card 2 Home ...
Federal Register notice: FDA seeks comments on an information collection extension entitled Evaluation of the Program for Enhanced Review Transparency...
FDA warns Iotech International it is marketing two misbranded, unapproved new Covid-19 drugs in the U.S.
FDA alerts people to potential injury if at-home Covid-19 tests are not used according to the approved manufacturer instructions.
FDA grants emergency use authorization for an Indicaid rapid at-home over-the-counter Covid-19 antigen test.
FDA approves Marinus Ztalmy to treat a rare form of epilepsy in patients age 2 and older.
FDA gives 510(k) clearance to the BioMrieux Vitek MS Prime next-generation mass spectrometry system.