On February 17, 2026, the U.S. Food and Drug Administration (FDA) approved FILKRI (filgrastim-laha), a biosimilar to Amgen’s NEUPOGEN (filgrastim). FILKRI was developed by Accord BioPharma, the U.S.
The Food and Drug Administration approved Udenyca Onbody, an administration device for Udenyca, a biosimilar of Neulasta. The Food and Drug Administration (FDA) approved Udenyca Onbody, an injector ...
PURPOSE: This multicenter, randomized, double-blind, active-control study was designed to determine whether a single subcutaneous injection of pegfilgrastim (SD/01, sustained-duration filgrastim; 100 ...
The US Food and Drug Administration (FDA) on Friday approved the 12 th biosimilar, Pfizer’s Nivestym (filgrastim-aafi), which is a biosimilar to Amgen’s Neupogen (filgrastim), for all eligible ...
The US Food and Drug Administration (FDA) has expanded the indication for tbo-filgrastim (Granix, Teva), now allowing it to be self-administered by patients and their caregivers. Tbo-filgrastim, a ...