In 2015, the Neulasta On-Body Injector (OBI) Onpro device was introduced as a less costly method of pegfilgrastim administration. While the device has been found to be safe in healthy volunteers and ...
Neulasta Delivery Kit Provides New Option for Patients Amgen announced the launch of Neulasta (pegfilgrastim) Delivery Kit that allows the healthcare provider to initiate Neulasta on the same day as ...
Neulasta Delivery Kit Provides Administration Option for Patients who may not Otherwise Need to Return to Clinic or Hospital the day After Chemotherapy One of the most common side effects of ...
Armlupeg, a biosimilar to Neulasta, is approved for reducing febrile neutropenia in non-myeloid malignancy patients undergoing myelosuppressive chemotherapy. Lupin's FDA-approved facility in India ...
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 ...
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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 ...
Amgen discussed the drug-delivery approaches to two of its biologics in a recent second-quarter earnings call. Amgen executives don’t seem too concerned that a viable competitor to the company’s ...
Credit: Coherus. The on-body injector includes features such as a retractable needle mechanism, an indicator, status light and auditory signal to help patients confirm the dose has been administered.
In its second untitled letter of 2021, the US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) flagged issues with Amgen’s promotion of its biological product Neulasta ...
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