Amgen Issues Statement in Response to Revised ESA Labeling Received from the FDA Today

Amgen Issues Statement in Response to Revised ESA Labeling Received from the FDA Today

THOUSAND OAKS, Calif.--(BUSINESS WIRE)--July 30, 2008--Amgen (NASDAQ: AMGN) issued the following statement in response to the receipt today of the complete response on the revised ESA labeling from the FDA.

"This label is consistent with our expectations. We will soon be communicating the revised product labeling for ESAs to both physicians and patients."

The potential impact of this revised label was factored into our updated guidance announced July 28, 2008.

CONTACT: Amgen, Thousand Oaks
Trish Hawkins, 805-447-5631 (media)
Arvind Sood, 805-447-1060 (investors)

SOURCE: Amgen

Sponsored by GenScript

Accelerate Biologics, Gene and Cell Therapy Product Development partnering with GenScript ProBio

GenScript ProBio is the bio-pharmaceutical CDMO segment of the world’s leading biotech company GenScript, proactively providing end-to-end service from drug discovery to commercialization with professional solutions and efficient processes to accelerate drug development for customers.

Suggested Articles

City of Hope and Canadian biotech Biovaxys Technology reported positive animal data for their COVID vaccines that could offer alternatives to mRNA.

4D is adding a trio of executives to spearhead its work in heart, eye and lung diseases as it pushes programs into and through the clinic.

Janssen has sent off its mutation-specific non-small cell lung cancer drug amivantamab to the FDA.