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30 April 2015 | By Victoria White
The FDA will review data supporting Amgen’s Biologics License Application (BLA) for Repatha (evolocumab) for the treatment of high cholesterol...
31 March 2015 | By Victoria White
Amgen has announced that the FDA has accepted the sNDA of Kyprolis for the treatment of patients with relapsed multiple myeloma...
2 March 2015 | By Amgen
Study met primary endpoint of progression-free survival patients receiving Kyprolis lived twice as long without disease progression...
2 March 2015 | By Amgen
Amgen announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion to extend the marketing authorization for Vectibix® (panitumumab) to include combination with FOLFIRI (an irinotecan-based chemotherapy) as first-line treatment in adult patients with wild-type RAS metastatic colorectal cancer (mCRC)...
Amgen (NASDAQ:AMGN) has announced new data from three separate analyses of Phase 2 and 3 studies evaluating evolocumab, a novel investigational low-density lipoprotein cholesterol (LDL-C)-lowering medication.
Michael J. Miller discusses rapid microbiological methods and the regulatory environment, the Online Water Bioburden Analyzer Workgroup look at the path to implementing Online Water Bioburden Analyzers, plus RMM roundtable...
21 October 2014 | By Amgen
Amgen announced the appointment of R. Sanders Williams, M.D., president of Gladstone Institutes and Gladstone's Robert W. and Linda L. Mahley Distinguished Professor...
3 September 2014 | By Amgen
First Marketing Authorization Application for an oncolytic immunotherapy in the European Union...
28 August 2014 | By Amgen
...in combination with statins in Japanese patients with high cardiovascular risk and high cholesterol.
20 August 2014 | By Amgen
Amgen announced that Elliott M. Levy, M.D., has been named senior vice president, Global Development, effective Sept. 8, 2014...
19 August 2014 | By Amgen
Amgen announced that a second placebo-controlled Phase 3 study evaluating AMG 416 for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease, receiving hemodialysis, met its primary and all secondary endpoints...
15 August 2014 | By Amgen
Amgen and its subsidiary, Onyx Pharmaceuticals, Inc., announced that the Phase 3 clinical trial FOCUS did not meet its primary endpoint of improving overall survival...
14 August 2014 | By Amgen
Amgen initiated a voluntary recall on June 26, 2014 for nine packaged lots of Aranesp® (darbepoetin alfa) (500 mcg) prefilled syringes from non-U.S. distributors, wholesalers and a number of hospital pharmacies...
4 August 2014 | By Amgen
Amgen and its subsidiary, Onyx Pharmaceuticals, Inc., announced that a planned interim analysis demonstrated that the Phase 3 clinical trial ASPIRE met its primary endpoint of progression-free survival...
18 July 2014 | By Amgen
Amgen announced that a Phase 3 study evaluating AMG 416 (formerly known as velcalcetide) for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease...
