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Amgen and Onyx’s MAA for Kyprolis is accepted by EMA

Amgen and Onyx’s MAA for Kyprolis is accepted by EMA

27-02-2015

The European Medicines Agency has accepted the Marketing Authorization Application for Kyprolis (carfilzomib)…

AmgenEuropeKyprolisOncologyOnyx PharmaceuticalsPharmaceuticalRegulation

Amgen and Onyx submit Kyprolis sNDA and marketing authorization application in USA and EU

Amgen and Onyx submit Kyprolis sNDA and marketing authorization application in USA and EU

28-01-2015

USA-based Amgen, the world’s leading independent biotech firm, and its subsidiary Onyx Pharmaceuticals…

AmgenKyprolisOncologyOnyx PharmaceuticalsPharmaceuticalRegulationUSA

Sanofi and Regeneron’s Praluent BLA gains priority review from US FDA

26-01-2015

The US Food and Drug Administration has accepted for priority review the Biologics License Application…

alirocumabAmgenBiotechnologyCardio-vascularevolocumabPraluentRegeneron PharmaceuticalsRegulationSanofiUSA

Samsung Bioepis' Enbrel biosimilar candidate SB4 accepted for review by EMA

Samsung Bioepis' Enbrel biosimilar candidate SB4 accepted for review by EMA

21-01-2015

South Korea’s Samsung Bioepis says that the Marketing Authorization Application for its Enbrel (etanercept)…

AmgenAnti-Arthritics/RheumaticsBiogen IdecBiosimilarsBiotechnologyEnbrelEuropePfizerRegulationSamsung Bioepis

Hospira submits new BLA for epoetin alfa biosimilar In USA

12-01-2015

US injectable drugs and infusion technologies and biosimilars developer Hospira has submitted a Biologics…

AmgenBiosimilarsBiotechnologyepoetinEpogenHematologyHospiraJanssenJohnson & JohnsonProcritRegulationRetacritUSA

Sandoz’ Neupogen biosimilar backed by FDA advisory panel

Sandoz’ Neupogen biosimilar backed by FDA advisory panel

08-01-2015

The US Food and Drug Administration Oncologic Drugs Advisory Committee (ODAC), in a unanimous vote, recommended…

AmgenBiosimilarsBiotechnologyFilgrastimNeupogenNovartisOncologyRegulationSandozUSAZarxio

FDA staffers back approval of Novartis' biosimilar of Amgen's Neupogen

FDA staffers back approval of Novartis' biosimilar of Amgen's Neupogen

06-01-2015

In briefing papers ahead of an advisory committee meeting, agency staff at the US Food and Drug Administration…

AmgenBiosimilarsBiotechnologyImmunologicalsNeupogenNovartisRegulationUSA

FDA approves new indication for Amgen's Xgeva

FDA approves new indication for Amgen's Xgeva

08-12-2014

USA-based Amgen says the US Food and Drug Administration has approved a new indication for Xgeva (denosumab),…

AmgenBiotechnologyOncologyRare diseasesRegulationUSAXgeva

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