FDA Pipeline: What’s New in Biosimilars, Drug Reviews, Designations, and More

November 14, 2018 – The U.S. Food and Drug Administration (FDA) recently issued the following new approvals and designations: Approval for Pegfilgrastim Biosimilar. The FDA recently approved a pegfilgrastim biosimilar, pegfilgrastim-cbqv. The biosimilar has been approved to decrease the incidence of infection as manifested by febrile neutropenia in patients receiving myelosuppressive chemotherapy associated with a clinically significant incidence of .. (leggi tutto)