- The Wall Street Journal•4 hours ago
Amgen Inc. said Wednesday that government regulators have rejected its new drug application for its therapy for a hormonal imbalance common in patients on dialysis.
- PR Newswire•5 hours agoAmgen Provides Update On Status Of Parsabiv™ (Etelcalcetide) New Drug Application (NDA) Submitted To The U.S. Food And Drug Administration (FDA)
THOUSAND OAKS, Calif., Aug. 24, 2016 /PRNewswire/ -- Amgen (AMGN) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter for the New Drug Application (NDA) for Parsabiv™ (etelcalcetide) for the treatment of secondary hyperparathyroidism (sHPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. Amgen is reviewing the Complete Response Letter, and we anticipate a post-action meeting with the FDA later this year to discuss the Complete Response.
Amgen Inc. (AMGN)
NasdaqGS - NasdaqGS Real Time Price. Currency in USD
|Bid||170.27 x 300|
|Ask||171.00 x 500|
|Day's Range||170.28 - 174.87|
|52wk Range||130.09 - 176.64|
|1y Target Est||N/A|
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