Federal Register notice: FDA announces a 5/9 Science Board meeting that is intended to provide recommendations on the agencys Innovation Funds work pl...
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...
FDA Review posts the Federal Register notices for the week ending 4/21/2017.
FDA classifies as Class 1 a Medtronic recent recall of all unused units of the StrataMR adjustable valves and shunts due to an increase in product com...