FDA accepts for priority review an Amgen supplemental BLA for Blincyto (blinatumomab) for treating early-stage, CD19-positive B-cell precursor acute l...
Four Hogan Lovells attorneys say medical device companies should begin now to prepare for the implementation of FDAs new Quality Management System Reg...
Office of Generic Drugs associate director of stakeholder and global engagement Sarah Ibrahim says FDA and EMA are evaluating a new pilot parallel sci...
Gilead Sciences discontinues its Phase 3 ENHANCE-3 study of magrolimab in acute myeloid leukemia (AML) after FDA placed a clinical hold on it due to a...
Federal Register notice: FDA posts a listing of six information collections that have been approved by OMB.
FDA accepts for priority review a GSK supplemental BLA to extend the indication of its Arexvy adjuvanted respiratory syncytial virus vaccine to adults...
FDA commissioner Robert Califf and two of his top associates describe how the agency uses its role to help address common chronic diseases.
Bipartisan members of the House introduce legislation to require FDA to produce a final rule to implement animal testing reforms approved at the end o...
