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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

FDA suspends pediatric trial of Amgen's Sensipar after patient death

27-02-2013

The US Food and Drug Administration revealed yesterday that it has stopped all pediatric clinical trials…

AmgenBiotechnologyRegulationResearchSensipar

US biotech giants lobbying to block biosimilars, NTY claims

31-01-2013

Some of the USA's biggest biotechnology companies are lobbying intensively to limit generic competition…

AmgenBiotechnologyGenentechGenericsNorth AmericaPoliticsRegulation

FDA approves SOBI's Kineret for the treatment of NOMID

08-01-2013

Biotech firm Swedish Orphan Biovitrum (STO: SOBI) today announced that the US Food and Drug Administration…

AmgenBiotechnologyInflammatory diseasesKineretNorth AmericaRegulationSobiSwedish Orphan Biovitrum

Amgen's Xgeva gets NICE backing for bone metastasis

24-10-2012

New guidance published today (October 24) by the UK's drugs watchdog the National Institute for Health…

AmgenBiotechnologyEuropeOncologyPricingRegulationXgeva

Amgen's Prolia gets FDA nod for men with osteoporosis

24-09-2012

The US Food and Drug Administration last week approved a new indication for world biotech leader Amgen's…

AmgenAnti-Arthritics/RheumaticsBiotechnologyMen's HealthNorth AmericaProliaRegulation

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