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...
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Federal Register notice: FDA makes available a draft guidance entitled Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-C...
FDA accepts for review a Pfizer NDA for baldness drug ritlecitinib for treating adults and adolescents with alopecia areata.
Federal Register notice: FDA makes available a final guidance entitled Submitting Documents Using Real-World Data and Real-World Evidence to FDA for D...
FDA publishes a final guidance on identifying real-world data and real-world evidence submitted in INDs, NDAs, and BLAs.
