Regulation - Nephrology and Hepatology, Pharmaceutical

Filter

Popular Filters

1 to 25 of 30 results

NICE issues new quality standard to prevent hepatitis B transmission

NICE issues new quality standard to prevent hepatitis B transmission

28-07-2014

On World Hepatitis Day today, the UK’s clinical standards body, the National Institute for Health and…

BaracludeBristol-Myers SquibbGilead SciencesHealthHepatitis BHepatologyMedicineNephrology and HepatologyPharmaceuticalPurinesRegulationUKViread

Veloxis and Chiesi receive approval from European Commission on anti-organ rejection drug

Veloxis and Chiesi receive approval from European Commission on anti-organ rejection drug

28-07-2014

Denmark-based Veloxis Pharmaceuticals and Italian company Chiesi Farmaceutici have said that the European…

Chiesi FarmaceuticiDenmarkEnvarsusEuropean CommissionItalyNephrology and HepatologyOrgan transplantsPharmaceuticalRegulationVeloxis Pharmaceuticals

Highlights of EMA Pharmacovigilance committee July meeting

Highlights of EMA Pharmacovigilance committee July meeting

14-07-2014

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) concluded two safety…

bromocriptineEuropeNephrology and HepatologyNeurologicalPharmaceuticalRegulationRiensoTakeda Pharmaceuticalvalproate Sodium InjectionWomen's Health

Otsuka’s Samsca, first ADPKD therapy, approved in Japan

25-03-2014

Japanese drugmaker Otsuka Pharmaceutical says it has become the first company in the world to obtain…

Asia-PacificJapanNephrology and HepatologyOtsukaPharmaceuticalRegulationSamsca

Keryx Biopharma files for EU approval of Zerenex

Keryx Biopharma files for EU approval of Zerenex

10-03-2014

US drugmaker Keryx Biopharmaceuticals has submitted a Marketing Authorization Application to the European…

EuropeKeryx BiopharmaceuticalsNephrology and HepatologyPharmaceuticalRegulationZerenex

FDA cites insufficient information in response to AMAG’s Feraheme application

FDA cites insufficient information in response to AMAG’s Feraheme application

23-01-2014

US drug company AMAG Pharmaceuticals (Nasdaq: AMAG) has received a complete response letter from the…

AMAG PharmaceuticalsFerahemeHematologyNephrology and HepatologyPharmaceuticalRegulationUSA

Velphoro receives US FDA approval for hyperphosphatemia in CKD

Velphoro receives US FDA approval for hyperphosphatemia in CKD

28-11-2013

Switzerland-based Vifor Pharma has received US Food and Drug Administration approval for Velphoro for…

Nephrology and HepatologyPharmaceuticalRegulationUSAVelphoroVifor Pharma

US orphan status for Pharmalink’s Busulipo

US orphan status for Pharmalink’s Busulipo

29-10-2013

Swedish specialty pharma group Pharmalink says its product Busulipo, (busulfan), a best-in-class conditioning…

BusulipoNefeconNephrology and HepatologyNorth AmericaOncologyPharmaceuticalPharmaLinkRegulationResearch

Otsuka's Samsca gains additional indication in Japan

17-09-2013

Japanese drugmaker Otsuka (TYO: 4768) says that its vasopressin V2 receptor antagonist Samsca (tolvaptan)…

Asia-PacificNephrology and HepatologyOtsukaPharmaceuticalRegulationSamscatolvaptan

Setback for Otsuka's tolvaptan

30-08-2013

The US subsidiary of Japanese drugmaker Otsuka Pharmaceutical (TYO: 4768) has received a Complete Response…

Nephrology and HepatologyOtsukaPharmaceuticalRegulationRest of the Worldtolvaptan

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

Added benefit of Mitsubishi Tanabe's colestilan not proven, says German IQWiG

10-07-2013

In an early benefit assessment under the Act on the Reform of the Market for Medicinal Products (AMNOG),…

BindRencolestilanEuropeMitsubishi TanabeNephrology and HepatologyPharmaceuticalPricingRegulation

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

Positive EU regulatory news for Alexza and Ferrer, but not Gentium

22-02-2013

USA-based Alexza Pharmaceuticals (Nasdaq: ALXA) and Spanish partner Grupo Ferrer Internacional have received…

AdasuveAlexza PharmaceuticalBiotechnologydefibrotideEuropeFerrer InternacionalGentiumNephrology and HepatologyNeurologicalPharmaceuticalRegulation

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

Keryx Biopharma rockets on new Zerenex data and plans to file for approval

29-01-2013

USA-based Keryx Biopharmaceuticals (Nasdaq: KERX) saw its shares close up a whopping 77% to $4.70 in…

BiotechnologyKeryx BiopharmaceuticalsNephrology and HepatologyPharmaceuticalRegulationRenagelRenvelaResearchSanofiZerenex

Novartis' Votubia cleared for non-cancerous kidney tumors in EU

05-11-2012

Swiss drug major Novartis' (NOVN: VX) shares rose 1.1% this morning, as the company revealed it has received…

EuropeNephrology and HepatologyNovartisPharmaceuticalRegulationVotubia

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

Japanese filings for Shionogi's metreleptin and Otsuka's tolvaptin

06-08-2012

Japanese drugmaker Shionogi (TYO: 4507) said last week that it has filed a New Drug Application with…

Asia-PacificmetreleptinNephrology and HepatologyOtsukaPharmaceuticalRare diseasesRegulationSamscaShionogitolvaptin

Regulatory filing preparations underway for Vifor's PA21 on good Ph III results

09-07-2012

The pivotal Phase III clinical study shows that the new phosphate binder PA21 successfully controls hyperphosphatemia…

FreseniusGalenicaNephrology and HepatologyPA21PharmaceuticalRegulationResearchVifor Pharma

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

1 to 25 of 30 results

Company Spotlight

ImmunoGen

ImmunoGen

Back to top