FDA approves a Novo Nordisk BLA for Esperoct (turoctocog alfa pegol) for treating adults and children with hemophilia A.
The Justice Department says the government has intervened in a whistleblower case alleging that Arriva Medical submitted false claims to Medicare for ...
FDA accepts for priority review an AbbVie NDA for upadacitinib and its use in treating adult patients with moderate to severe rheumatoid arthritis.
FDA Review posts the Federal Register notices for the week ending 2/15/2019.
FDA Review posts product approval summaries for the week ending 2/15/2019
Federal Register notice: FDA reopens the comment period on a 12/7/2018 notice entitled Framework for a Real-World Evidence Program; Availability.
Federal Register notice: FDA announces a 3/25-26 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee meeting that will...
Federal Register notice: CDER provides an opportunity for a limited number of applicants to participate in an Established Conditions Pilot Program.