Rolvedon is a long-acting granulocyte colony-stimulating factor.
White Blood Cell Disorders
Rolvedon Approved for Chemotherapy-Induced Neutropenia
Rolvedon is a novel, long-acting granulocyte colony-stimulating factor comprised of 2 protein components, an analogue of G-CSF and an Fc antibody fragment.
Stimufend, a Biosimilar to Neulasta, Gets FDA Approval
The approval was based on a review of a comprehensive data package and a totality of evidence demonstrating a high degree of similarity of Stimufend to the reference product.
Fylnetra, a Biosimilar to Neulasta, Gets FDA Approval
The approval was based on data demonstrating a high degree of similarity of Fylnetra to the reference product, with no clinically meaningful differences.
FDA Accepts Resubmitted Eflapegrastim BLA for Chemotherapy-Induced Neutropenia
The BLA is supported by data from two phase 3 trials that evaluated eflapegrastim in early-stage breast cancer patients.
Biosimilar Releuko Gets FDA Approval
Approval was based on data demonstrating similarity between the 2 the biosimilar and reference product, Neupogen.
FDA Needs More Data on Plinabulin for Chemotherapy-Induced Neutropenia
Plinabulin is an investigational first-in-class selective immunomodulating microtubule-binding agent.
Manufacturing Deficiencies Delay Decision on Eflapegrastim
Eflapegrastim is a novel, long-acting G-CSF comprised of 2 protein components, an analogue of G-CSF and an Fc antibody fragment.
Neulasta Ad Claims Misleading, May Undermine Biosimilar Use, Says FDA
The ad claims that there is a higher risk of febrile neutropenia when pegfilgrastim is administered via prefilled syringe vs Neulasta Onpro on-body injector.
