Amgen ads talking up its Neulasta on-body injection system caught the FDA’s attention—with the help of some “Bad Ad” tattlers. The FDA slapped Amgen with an untitled letter last week for banner ad ...

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 ...

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 ...

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. The Food and Drug Administration (FDA) has ...

Udenyca Onbody is expected to be available in the first quarter of 2024 and will be supplied in a carton containing 1 on-body injector co-packaged with 1 prefilled syringe. The Food and Drug ...

Amgen has received a letter from the FDA cautioning it against making misleading claims in advertising about its pegfilgrastim injector. The wording used in the advertisements claimed that the Onpro ...

Ivo Abraham, PhD, RN, a professor with the University of Arizona Health Sciences in the Department of Pharmacy Practice, talks about the role that the pandemic has played in the struggle between ...

Neulasta (pegfilgrastim) is a prescription drug used to prevent infection from certain cancer therapy and to treat radiation sickness. Neulasta’s cost may depend on factors such as your dosage and the ...

Before you start treatment with Neulasta, tell your doctor and pharmacist which prescription, over-the-counter, and other medications you take. By sharing this information with them, you may help ...