Nasdaq

Nplate® (romiplostim) Now Approved For Earlier Use In Adults With Immune Thrombocytopenia

THOUSAND OAKS, Calif., Oct. 18, 2019 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) approved Amgen's Supplemental Biologics License Application ...
FierceBiotech

Amgen and FDA Agree to Modify Nplate® (Romiplostim) Risk Evaluation and Mitigation Strategy

THOUSAND OAKS, Calif., Dec. 6, 2011 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the U.S. Food and Drug Administration (FDA) has modified the requirements of the Nplate® (romiplostim) Risk ...
FiercePharma

Additional Key Nplate Data Also Presented at American Society of Hematology Annual Meeting

THOUSAND OAKS, Calif., Dec. 13, 2011 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that data from several key Nplate ® (romiplostim) studies were presented at the 53rd Annual Meeting and ...
Monthly Prescribing Reference

Nplate Indication Expanded to Include Pediatric Patients With ITP

The expanded approval was supported by data from 2 double-blind, placebo-controlled trials in patients aged ≥1 year with ITP for at least 6 months. The Food and Drug Administration (FDA) has approved ...
FierceBiotech

Nplate (Romiplostim) Receives Positive Opinion for Marketing Authorisation in the European Union

First and Only Approved Platelet Producer Represents New Treatment Approach for Serious Chronic Autoimmune Disorder THOUSAND OAKS, Calif., November 21, 2008 ...