BioMarin Pharmaceutical tells FDA a patient participating in the companys hemophilia A Phase 3 gene therapy trial of valoctocogene roxaparvovec (BMN 2...
Federal Register notice: FDA makes available a draft guidance entitled Statement of Identity and Strength Content and Format of Labeling for Human No...
Teva urges the U.S. Supreme Court to dismiss a GlaxoSmithKline argument that the high court should not hear Tevas appeal of a skinny label case involv...
FDA clears a Boston Imaging 510(k) for its V7, an ultrasound system said to enhance image clarity.
FDA approves Spectrum Pharmaceuticals Rolvedon (eflapegrastim-xnst) injection for decreasing febrile neutropenia-associated infections in certain adul...
FDA selects non-profit PATHs chief scientific officer David Kaslow as CBER Office of Vaccines Research and Review director.
Federal Register notice: FDA revokes two emergency use authorizations one issued to Becton Dickinson and the other to Talis Biomedical.
Federal Register notice: FDA makes available a draft guidance entitled Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-C...
