Pharmaceutical - Diabetes, Regulation

Filter

Current filters:

DiabetesRegulation

Popular Filters

1 to 25 of 146 results

Merck & Co submits first regulatory filing for omarigliptin, in Japan

Merck & Co submits first regulatory filing for omarigliptin, in Japan

25-11-2014

US pharma giant Merck & Co has submitted a new drug application for omarigliptin, its investigational…

DiabetesJapanMerck & CoomarigliptinPharmaceuticalRegulation

CHMP positive opinion on Victoza in type 2 diabetes patients with moderate renal impairment

CHMP positive opinion on Victoza in type 2 diabetes patients with moderate renal impairment

21-11-2014

The European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive…

DiabetesEuropeNovo NordiskPharmaceuticalRegulationVictoza

Added benefit of Jardiance not proven, says IQWiG

19-11-2014

Following an examination as to whether Jardiance (empagliflozin) offers an added benefit over appropriate…

Boehringer IngelheimDiabetesEli LillyGermanyJardiancePharmaceuticalPricingRegulation

SMC accepts Eylea and Onglyza for use in NHS Scotland

SMC accepts Eylea and Onglyza for use in NHS Scotland

13-11-2014

The Scottish Medicines Consortium (SMC) has accepted German drugmaker Bayer’s Eylea (aflibercept solution…

AstraZenecaBayerDiabetesEyleaOnglyzaPharmaceuticalRegulationUK

US FDA approves AstraZeneca’s Xigduo XR

US FDA approves AstraZeneca’s Xigduo XR

30-10-2014

The US Food and Drug Administration has approved Anglo-Swedish pharma major AstraZeneca’s once-daily…

AstraZenecaDiabetesPharmaceuticalRegulationUSAXigduo XR

Eli Lilly's Humalog KwikPen approved in Europe for new 200 units/ml version

Eli Lilly's Humalog KwikPen approved in Europe for new 200 units/ml version

03-10-2014

US drug major Eli Lilly has received marketing authorization from the European Commission for its Humalog…

DiabetesEli LillyEuropeHumalogPharmaceuticalRegulation

FDA approves Lilly’s Trulicity to treat type 2 diabetes

FDA approves Lilly’s Trulicity to treat type 2 diabetes

19-09-2014

The US Food and Drug Administration yesterday approved pharma major Eli Lilly’s Trulicity (dulaglutide),…

BydureonDiabetesdulaglutideEli LillyPharmaceuticalRegulationTanzeumTrulicityUSAVictoza

First Ph III data in Japanese patients for Merck’s omarigliptin for type 2 diabetes

18-09-2014

US pharma giant Merck & Co has announced the presentation of the first data from the Phase III clinical…

DiabetesJapanMerck & CoomarigliptinPharmaceuticalRegulationResearch

EU approval for Boehringer and Lilly’s insulin glargine biosimilar

EU approval for Boehringer and Lilly’s insulin glargine biosimilar

10-09-2014

The European Commission granted marketing authorization for US drug major Eli Lilly and family-owned…

AbasriaBasaglarBiosimilarsBoehringer IngelheimDiabetesEli LillyEuropeInsulinLantusPharmaceuticalRegulationSanofi

The FDA publishes Novo Nordisk briefing documents ahead of Saxenda Advisory Committee meeting

The FDA publishes Novo Nordisk briefing documents ahead of Saxenda Advisory Committee meeting

09-09-2014

The US Food and Drug Administration has published briefing documents on Danish insulin giant Novo Nordisk’s…

Anti-diabetic drugsDiabetesliraglutideNovo NordiskPharmaceuticalRegulationTreatment of obesityUSA

UK NICE wants more info on type 2 diabetes drug Jardiance

UK NICE wants more info on type 2 diabetes drug Jardiance

28-08-2014

In a new draft guidance issued today, the UK drugs watchdog the National Institute for Health and Care…

Boehringer IngelheimDiabetesEli LillyJardiancePharmaceuticalPricingRegulationUK

Tentative FDA approval for Lilly and Boehringer Ingelheim's Basaglar

Tentative FDA approval for Lilly and Boehringer Ingelheim's Basaglar

19-08-2014

The US Food and Drug Administration yesterday granted tentative approval for Basaglar (insulin glargine…

AbasriaBasaglarBiosimilarsBoehringer IngelheimDiabetesEli LillyInsulin Glargine [rDNA origin] InjectionLantusPharmaceuticalRegulationUSA

FDA approves Janssen’s Invokamet for diabetes

09-08-2014

The US Food and Drug Administration has approved US health care giant Johnson & Johnson subsidiary Janssen…

DiabetesInvokametInvokanaJanssenJohnson & JohnsonPharmaceuticalRegulationUSA

Added benefit of Novo Nordisk’s Tresiba not proven, says IQWiG

Added benefit of Novo Nordisk’s Tresiba not proven, says IQWiG

08-08-2014

In an early benefit assessment under the German Act on the Reform of the Market for Medicinal Products…

DiabetesGerman Institute for Quality and EfficiencyGermanyNovo NordiskPharmaceuticalPricingRegulationTresiba

US FDA approves Jardiance for adults with type 2 diabetes

US FDA approves Jardiance for adults with type 2 diabetes

02-08-2014

The US Food and Drug Administration on Friday approved Jardiance (empagliflozin) tablets as an adjunct…

Boehringer IngelheimDiabetesEli LillyEuropeGermanyJardiancePharmaceuticalRegulationUSA

Sanofi's NDA for basal insulin Toujeo accepted by FDA

Sanofi's NDA for basal insulin Toujeo accepted by FDA

08-07-2014

The US Food and Drug Administration has accepted for review French pharma major Sanofi’s New Drug Application…

DiabetesPharmaceuticalRegulationSanofiToujeoUSA

Japan marketing approval for Canaglu; vaccine license for Daiichi Sankyo

Japan marketing approval for Canaglu; vaccine license for Daiichi Sankyo

04-07-2014

Japanese drug major Mitsubishi Tanabe Pharma has received approval to manufacture and market the SGLT2…

canagliflozinCanagluDaiichi SankyoDiabetesJapanMitsubishi TanabePharmaceuticalRegulationSanofi PasteurVaccines

FDA approves MannKind’s Afrezza to treat diabetes

FDA approves MannKind’s Afrezza to treat diabetes

30-06-2014

In a much awaited decision, the US Food and Drug Administration on Friday approved MannKind Corp’s…

AfrezzaDiabetesMannKindPharmaceuticalRegulationUSA

FDA review of CV risks for diabetics taking olmesartan not conclusive

FDA review of CV risks for diabetics taking olmesartan not conclusive

25-06-2014

The US Food and Drug Administration has completed its safety review and has found no clear evidence of…

BenicarCardio-vascularDaiichi SankyoDiabetesolmesartanPharmaceuticalRegulationUSA

UK’s NICE approves Janssen’s Invokana for type 2 diabetes

UK’s NICE approves Janssen’s Invokana for type 2 diabetes

25-06-2014

The UK’s National Institute for Health and Care Excellence (NICE) has issued new final guidance recommending…

DiabetesInvokanaJanssenPharmaceuticalRegulationUK

Boehringer and Lilly re-file empagliflozin NDA with FDA

Boehringer and Lilly re-file empagliflozin NDA with FDA

19-06-2014

The US subsidiary of German family-owned drugmaker Boehringer Ingelheim and pharma major Eli Lilly have…

Boehringer IngelheimDiabetesEli LillyempagliflozinPharmaceuticalRegulationUSA

1 to 25 of 146 results

Back to top