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FDA approved enzalutamide (XTANDI, Astellas Pharma US, Inc.), for patients with castration-resistant prostate cancer (CRPC). More Information.  July 13, 2018

Filgrastim-aafi FDA approved as Filgrastim Biosimilar

On July 20, the FDA approved filgrastim-aafi (Nivestym®, Pfizer), as a biosimilar to filgrastim (Neupogen, Amgen). The label includes all indications of the reference product.

FDA approved biosimilar pegfilgrastim to decrease the chance of febrile neutropenia in patients with non-myeloid cancers on myelosuppressive chemotherapy

 

  • FDA approved Fulphila (pegfilgrastim-jmdb, Mylan GmbH), a biosimilar of Neulasta (pegfilgrastim, Amgen, Inc.) to decrease the chance of infection due to febrile neutropenia in patients receiving myelosuppressive chemotherapy with clinically significant incidence of febrile neutropenia and with non-myeloid cancers.