FDA clears a Diazyme Laboratories 510(k) for the Procalcitonin assay for use in diagnosing sepsis.
Federal Register notice: FDA announces a 5/17 Vaccines and Related Biological Products Advisory Committee meeting.
Thermo Fisher Scientific and SpeeDx agree to develop and submit for FDA clearance the ResistancePlus MG Test for detecting M. genitalium, a rapidly gr...
Apotex petitions FDA to impose stricter approval requirements for applicants seeking approval for a biosimilar product referencing Amgens Neulasta (pe...
Eli Lilly says it will file an NDA for abemaciclib based on data from a Phase 3 breast cancer study called MONARCH 3 that met its primary endpoint of ...
Hospira recalls one lot of 25% dextrose injection, USP, (infant) pre-filled syringe due to the presence of particulate matter, identified as human hai...
FDA approves a Samsung Bioepis abbreviated BLA for Renflexis (infliximab-abda), a biosimilar of Janssens Remicade.
Federal Register notice: CDER announces a one-day (6/15) public symposium on Safe Use Symposium: A Focus on Reducing Preventable Harm From Drugs in th...