FDA posts upcoming changes to the clozapine REMS (risk evaluation and mitigation strategy).
FDA releases the transcript from a 5/6 CBER virtual workshop on patient engagement and regenerative medicine.
FDA clears a Volpara Health 510(k) for the latest version of its key science algorithm, Volpara Imaging Software (VIS 3.2), a breast density assessmen...
FDA accepts for a priority review a Genentech BLA for faricimab for treating wet, or neovascular, age-related macular degeneration and diabetic macula...
Researchers say many reporters to the FDA MAUDE medical device database misclassify deaths in other categories.
FDA says Emergent BioSolutions can resume producing J&J Covid-19 vaccine at its Bayview manufacturing facility.
FDA approves Mylans Semglee, the first biosimilar and interchangeable insulin product approved in the U.S.
Federal Register notice: FDA determines that Eli Lillys Ceclor CD (cefaclor extended-release tablets) 375 mg and 500 mg were not withdrawn from sale f...