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 ...

Filgrastim alone and sequential sargramostim and filgrastim have been shown to be more effective than sargramostim alone in the mobilization of CD34 + cells after myelosuppressive chemotherapy (MC).

Sandoz is the first company to receive approval of a biosimilar in the US through the new FDA biosimilars pathway established under BPCIA Zarxio is approved for all indications included in the ...

Blinded, Randomized, Multicenter Study to Evaluate Single Administration Pegfilgrastim Once per Cycle Versus Daily Filgrastim as an Adjunct to Chemotherapy in Patients With High-Risk Stage II or Stage ...

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.

Novartis' (NVS) generic arm, Sandoz, announced that the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) has recommended the approval of its biosimilar version of ...

The digital press release with multimedia content can be accessed here: Holzkirchen, September 3, 2015 - Sandoz, a Novartis company, announced today that Zarxio(TM) (filgrastim-sndz) is now available ...

Patients older than 18 years with cancer, other than leukemia, who were candidates for autologous hematopoietic stem cell transplantation and in whom less than 2.5 × 10 6 CD34 + cells/kg were ...

A biosimilar version of filgrastim (EP2006, Sandoz/Novartis) has today been recommended for approval in the United States. The new product is like a generic version of the brand-name filgrastim, ...

Holzkirchen, March 6, 2015-Sandoz, a Novartis company, announced today that the US Food and Drug Administration (FDA) approved Zarxio(TM) (filgrastim-sndz) for all indications included in the ...