Regulation - Amgen

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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

US FDA grants earlier approval for Amgen’s Blincyto for rare form of lymphoblastic leukemia

US FDA grants earlier approval for Amgen’s Blincyto for rare form of lymphoblastic leukemia

04-12-2014

Ahead of the anticipated decision date, the US Food and Drug Administration yesterday approved Blincyto…

AmgenBiotechnologyblinatumomabBlincytoOncologyRegulationUSA

EMA PRAC’s recommendations to reduce risk of heart problems with ivabradine

09-11-2014

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed a…

AmgenCardio-vascularEuropeivabradinePharmaceuticalProcoralanRegulationServier

Amgen files BLA for BiTE immunotherapy blinatumomab

Amgen files BLA for BiTE immunotherapy blinatumomab

22-09-2014

USA-based Amgen has submitted a Biologics License Application (BLA) to the US Food and Drug Administration…

AmgenBiotechnologyblinatumomabOncologyRegulationUSA

Green Cross Neulapeg biosimilar approved in South Korea

28-08-2014

South Korea’s Green Cross says that the country’s Ministry of Food and Drug Safety has granted marketing…

AmgenAsia-PacificBiosimilarsBiotechnologyGreen CrossNeulapegNeulastaOncologyRegulation

FDA priority review for Amgen’s ivabradine in CHF

FDA priority review for Amgen’s ivabradine in CHF

27-08-2014

The US Food and Drug Administration has granted priority review designation for US biotech giant Amgen’s…

AmgenBiotechnologyCardio-vascularivabradineRegulationServierUSA

Amgen issues voluntary recall of Aranesp prefilled syringes in certain countries

Amgen issues voluntary recall of Aranesp prefilled syringes in certain countries

15-08-2014

USA-based Amgen initiated a voluntary recall on June 26 for nine packaged lots of anemia drug Aranesp…

AmgenAnemiaAranespBiotechnologyMarkets & MarketingOncologyRegulation

Sandoz application for biosimilar Neupogen accepted by US FDA

25-07-2014

The US Food and Drug Administration has accepted the Biologics License Application for filgrastim, which…

AmgenBiosimilarsBiotechnologyFilgrastimNeupogenNovartisOncologyRegulationSandozUSAZarzio

Breakthrough status for Amgen’s blinatumomab in ALL

01-07-2014

USA-based Amgen, the world's largest independent biotech firm, says that the US Food and Drug Administration…

AmgenBiotechnologyblinatumomabOncologyRegulationUSA

Amgen’s Vectibix approved for colorectal cancer by FDA

Amgen’s Vectibix approved for colorectal cancer by FDA

27-05-2014

USA-based Amgen, the world's leading independent biotech firm, has announced that the US Food and Drug…

AmgenBiotechnologyChemotherapy regimensMetastatic colorectal cancerOncologyRegulationUSAVectibix

Drug approvals for Bayer in USA and Japan

Drug approvals for Bayer in USA and Japan

23-11-2013

There were two pieces of good news for German Pharma and chemicals major Bayer on Friday (November 22),…

AmgenAsia-PacificBayerBiotechnologyEyleaNexavarNorth AmericaOncologyOnyx PharmaceuticalsOphthalmicsPharmaceuticalRegeneronRegulation

Daiichi Sankyo files Ranmark to treat giant cell tumor of bone in Japan

29-08-2013

Japanese drug major Daiichi Sankyo (TYO: 4568) has filed an application for approval in Japan to manufacture…

AmgenAsia-PacificDaiichi SankyoOncologyPharmaceuticalPraliaRanmarkRegulation

European Commission OK for Lonquex

09-08-2013

Israel-based Teva Pharmaceutical Industries (NYSE: TEVA|), the world's leading generics drugmaker, says…

AmgenEuropeLonquexOncologyPharmaceuticalRegulationTeva Pharmaceutical Industries

FDA backs Amgen's Xgeva for new use, to treat giant cell tumor of the bone

14-06-2013

The US Food and Drug Administration late yesterday (June 13) expanded the approved use of biotech major…

AmgenBiotechnologyNorth AmericaOncologyRegulationXgeva

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