Federal Register notice: FDA seeks consumer organizations interested in participating in the selection of voting and nonvoting consumer representative...
FDA says clinical trial results show an increased risk of death and serious side effects associated with Secura Bios cancer drug Copiktra.
FDA tells Covid-19 vaccine manufacturers seeking to update their vaccines that they should develop modified vaccines that add an omicron BA.4/5 spike ...
Three drug company stakeholders suggest changes to research proposed by the CDER Office of Prescription Drug Promotion.
FDA commissioner Robert Califf taps former Johns Hopkins School of Medicine professor Namandj N. Bumpus as the agencys new chief scientist, and former...
Senators Elizabeth Warren (D-MA) and Chuck Grassley (R-IA) urge FDA to finalize a proposed rule on making certain hearing aids available over the coun...
FDA extends by three months the review of a Provention Bio BLA for teplizumab, indicated for delaying progression to Stage 3 clinical Type 1 diabetes ...
Federal Register notice: FDA proposes to reclassify optical diagnostic devices for melanoma detection and electrical impedance spectrometers from Clas...