The road to an FDA nod for Coherus BioSciences’ China-made PD-1 inhibitor has been long and tortuous. After a complete response letter and delayed preapproval inspections, the FDA found a fresh ...
Neulasta (pegfilgrastim) is a brand-name drug that’s prescribed to treat radiation sickness and prevent certain complications of chemotherapy. Neulasta comes as an injectable solution. The dosage can ...
Amgen announced that the Neulasta (pegfilgrastim) Delivery Kit is now available in the United States (US). The Neulasta Delivery Kit includes a specially designed single-use prefilled syringe ...
Credit: Coherus BioSciences. The new autoinjector is designed with push-on-skin activation to be used in both in-office and at-home settings of care. The Food and Drug Administration (FDA) has ...
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. Stimufend, a leukocyte ...
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