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Showing posts with label amgen. Show all posts
Showing posts with label amgen. Show all posts

FDA Approves New Kyprolis Combination Therapy

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Amgen announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) of Kyprolis ® ...

European Commission Approves IMLYGIC As First Oncolytic Immunotherapy

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Amgen announced that the European Commission has approved the use of IMLYGIC ™ (talimogene laherparepvec) for the treatment of adults wit...

Amgen to Present IMLYGIC Data

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Amgen announced that the Company will present eight IMLYGIC (talimogene laherparepvec) abstracts, including data from the Phase 3 trial a...

Amgen present data on REPATHA

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Amgen announced that it will present 14 abstracts at the American Heart Association (AHA) Scientific Sessions 2015, from Nov. 7–11 in Orlan...

Amgen Receives CHMP Positive Opinions For Kyprolis

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Amgen announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted positive opin...

Amgen Submits Application To FDA For New Delivery Option For Monthly Administration Of Repatha

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Amgen  announced the submission of an application to the  U.S. Food and Drug Administration  ( FDA ) seeking approval of a single-dosing ...

Amgen Submits Marketing Authorization Application Etelcalcetide (AMG 416)

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Amgen announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) via the centralized pr...