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notice: FDA determines that Eli Lillys Ceclor CD (cefaclor extended-release tablets) 375 mg and 500 mg were not withdrawn from sale f...
The International Council for Harmonization says its Q13 guidance on drug continuous manufacturing is available for public comment.