Regulation - Regulation, Nephrology and Hepatology, North America

Keryx Biopharma files for US approval of Zerenex

09-08-2013

Keryx Biopharmaceuticals (Nasdaq: KERX) says it has submitted a New Drug Application to the US Food and…

BiotechnologyKeryx BiopharmaceuticalsNephrology and HepatologyNorth AmericaRegulationZerenex

Negative advisory view for Otsuka's tolvaptan in ADPKD

06-08-2013

Japanese drugmaker Otsuka Pharmaceutical (TYO: 4768) says that the US Food and Drug Administration's…

Nephrology and HepatologyNorth AmericaOtsukaPharmaceuticalRegulationtolvaptin

Vifor gains US FDA approval for Injectafer

26-07-2013

Switzerland-based Vifor Pharma, part of the Galenica group (SIX: GALN), has received approval from the…

FerinjectInjectaferLuitpold PharmaNephrology and HepatologyNorth AmericaPharmaceuticalRegulationVifor Pharma

US FDA accepts NDAs for Otsuka's tolvaptan and BTG's Varisolve

12-04-2013

Japanese mid-sized drugmaker Otsuka Pharmaceutical (TYO: 4578) says that the US Food and Drug Administration…

BTGCardio-vascularNephrology and HepatologyNorth AmericaOtsukaPharmaceuticalRare diseasesRegulationtolvaptanVarisolve

Vifor Fresenius PA21 filed for approval with US FDA, accepted by EMA

11-02-2013

A New Drug Application for PA21 (iron(III)-oxyhydroxide) has been submitted to the US Food and Drug Administration.…

EuropeFreseniusGalenicaNephrology and HepatologyNorth AmericaPA21PharmaceuticalRegulationVifor Pharma

FDA extends PDUFA date for Biogen Idec's MS drug BG-12; Abbott and Reata's bardoxolone stalled

19-10-2012

Shares of US biotech firm Biogen Idec (Nasdaq: BIIB) fell 3% to $149.50 in premarket trading yesterday,…

Abbott LaboratoriesbardoxoloneBG-12Biogen IdecBiotechnologyDiabetesNephrology and HepatologyNeurologicalNorth AmericaPharmaceuticalReata PharmaceuticalsRegulationResearch

AVEO and Astellas file NDA for tivozanib in kidney cancer

02-10-2012

USA-based AVEO Oncology (Nasdaq: AVEO) and Japanese drug major Astellas Pharma (TSE:4503) have submitted…

Astellas PharmaAVEO OncologyBiotechnologyNephrology and HepatologyNorth AmericaOncologyPharmaceuticalRegulationtivozanib

Affymax and Takeda get special Medicare code for Omontys

16-04-2012

USA-based Affymax (Nasdaq: AFFY) and the US subsidiary of Japanese drug major Takeda Pharmaceuticals…

AffymaxBiotechnologyNephrology and HepatologyNorth AmericaOmontysOncologypeginesatidePharmaceuticalPricingRegulationTakeda Pharmaceuticals

FDA backs Affymax and Takeda drug Omontys for anemia due to CKD

28-03-2012

The US Food and Drug Administration yesterday approved Omontys (peginesatide, formerly known as Hematide)…

AffymaxBiotechnologyNephrology and HepatologyNorth AmericaOmontyspeginesatidePharmaceuticalRegulationTakeda Pharmaceuticals

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