Regulation - Nephrology and Hepatology

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Three new drugs recommended for approval by EMA/CHMP

Three new drugs recommended for approval by EMA/CHMP

27-02-2015

Three new medicines have been recommended for approval at the February 2015 meeting of the European Medicines…

AmgenEuropeJinarcNephrology and HepatologyNovartisOncologyOtsuka PharmaceuticalPharmaceuticalRegulationRistempaVectibixZykadia

NICE final draft guidance recommends Norgine's Targaxan

NICE final draft guidance recommends Norgine's Targaxan

19-02-2015

The UK’s National Institute for Health and Care Excellence has published its final draft guidance recommending…

Nephrology and HepatologyNeurologicalNorginePharmaceuticalRegulationTargaxanUK

Biotie receives positive opinion on orphan drug status for BTT1023 from EMA

Biotie receives positive opinion on orphan drug status for BTT1023 from EMA

17-02-2015

Finnish biotech and pharma company Biotie has received a positive opinion from the European Medicines…

BiotechnologyBiotie TherapiesFinlandNephrology and HepatologyRegulation

AbbVie submits NDA to Japanese regulators for ombitasvir/ paritaprevir/ ritonavir combination in hepatitis C

AbbVie submits NDA to Japanese regulators for ombitasvir/ paritaprevir/ ritonavir combination in hepatitis C

12-02-2015

US drugmaker AbbVie has submitted a New Drug Application to the Japanese Ministry of Health, Labor and…

AbbVieJapanNephrology and Hepatologyombitasvir/paritaprevir/ritonavirPharmaceuticalRegulation

Rockwell's Triferic cleared for marketing by US FDA

26-01-2015

The US Food and Drug Administration has approved US biopharma company Rockwell Medical’s Triferic (ferric…

Nephrology and HepatologyPharmaceuticalRegulationRockwell MedicalTrifericUSA

IQWiG reports negative views on Provenge, Velphoro and Zydelig

IQWiG reports negative views on Provenge, Velphoro and Zydelig

22-01-2015

The German Institute for Quality and Efficiency in Health Care (IQWiG) has reviewed a number of dossiers…

DendreonGermanyGilead SciencesNephrology and HepatologyOncologyPharmaceuticalPricingProvengeRegulationVelphoroVifor PharmaZydelig

Novo Nordisk's Victoza granted label extension in the UK

Novo Nordisk's Victoza granted label extension in the UK

20-01-2015

A license extension has been granted in the UK for Victoza (liraglutide) from Danish insulin giant Novo…

Nephrology and HepatologyNovo NordiskPharmaceuticalRegulationUKVictoza

France negotiates lowest price in Europe for Gilead’s Sovaldi

France negotiates lowest price in Europe for Gilead’s Sovaldi

21-11-2014

The discount negotiated by the French government on hepatitis C drug Sovaldi (sofosbuvir), produced by…

FranceGilead SciencesNephrology and HepatologyPharmaceuticalPoliticsPricingRegulationSovaldi

Kissei files for Japanese approval of PA21 for hyperphosphatemia

21-11-2014

Japanese mid-sized drugmaker Kissei Pharmaceutical says that a new drug application for PA21 (development…

FreseniusJapanKissei PharmaceuticalNephrology and HepatologyPA21PharmaceuticalRegulationVelphoroVifor Pharma

Two Bristol-Myers Squibb drugs approved by Scottish Medicines Consortium

Two Bristol-Myers Squibb drugs approved by Scottish Medicines Consortium

10-11-2014

The Scottish Medicines Consortium has approved two new treatments today, one for skin cancer and one…

Bristol-Myers SquibbDaklinzaNephrology and HepatologyOncologyPharmaceuticalRegulationUKYervoy

Keryx' shares fall as FDA approves kidney drug, but with warnings

Keryx' shares fall as FDA approves kidney drug, but with warnings

07-09-2014

US drugmaker Keryx Biopharmaceuticals has received approval from the US Food and Drug Administration…

ferric citrateKeryx BiopharmaceuticalsNephrology and HepatologyPharmaceuticalRegulationRenvelaSanofiUSAZerenex

Bristol-Myers Squibb launches Daklinza in the UK for chronic hepatitis C

Bristol-Myers Squibb launches Daklinza in the UK for chronic hepatitis C

03-09-2014

US drug major Bristol-Myers Squibb has launched Daklinza (daclastavir) in the UK for chronic hepatitis…

AntiviralsBristol-Myers SquibbDaklinzaHepatitis CNephrology and HepatologyPharmaceuticalRegulationUK

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

Alnylam and TAP collaborate on ALN-AAT, for AAT deficiency-associated liver disease

Alnylam and TAP collaborate on ALN-AAT, for AAT deficiency-associated liver disease

19-06-2014

RNAi therapeutics company Alnylam Pharmaceuticals and The Alpha-1 Project (TAP), the venture philanthropy…

ALN-AATAlnylam PharmaceuticalsBiotechnologyNephrology and HepatologyRegulationResearchThe Alpha-1 ProjectUSA

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

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