Regulation - Boehringer Ingelheim

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FDA expands indication for Eliquis to treatment of DVT and PE

FDA expands indication for Eliquis to treatment of DVT and PE

22-08-2014

US pharma majors Bristol-Myers Squibb and Pfizer late yesterday said that the US Food and Drug Administration…

Boehringer IngelheimCardio-vascularEliquisPfizerPharmaceuticalPulmonary embolismRegulationUSA

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 panel recommends Boehringer drug for the maintenance treatment of COPD

FDA panel recommends Boehringer drug for the maintenance treatment of COPD

15-08-2014

There was good news late yesterday for German family-owned pharma major Boehringer Ingelheim, when an…

Boehringer IngelheimPharmaceuticalRegulationRespiratory and PulmonarySpirivatiotropiumUS Food and Drug AdministrationUSA

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

FDA approves Boehringer’s Striverdi Respimat for COPD

FDA approves Boehringer’s Striverdi Respimat for COPD

01-08-2014

The US Food and Drug Administration has approved German family-owned pharma major Boehringer Ingelheim’s…

Boehringer IngelheimPharmaceuticalPulmonologyRegulationRespiratory and PulmonaryStriverdi RespimatUSA

BMJ alleges Boehringer Ingelheim withheld Pradaxa dosing information from regulators

BMJ alleges Boehringer Ingelheim withheld Pradaxa dosing information from regulators

24-07-2014

German family-owned drug major Boehringer Ingelheim has been accused of withholding ‘important analyses’…

Boehringer IngelheimDabigatranGermanyHematologyPharmaceuticalPradaxaPyridinesRegulationUKUniversity of California

US breakthrough designation in IPF for Boehringer’s nintedanib

US breakthrough designation in IPF for Boehringer’s nintedanib

17-07-2014

The US Food and Drug Administration has granted Breakthrough Therapy designation for German family-owned…

Boehringer IngelheimnintedanibPharmaceuticalRegulationRespiratory and PulmonaryUSA

Boehringer Ingelheim’s Pradaxa available in UK for DVT

Boehringer Ingelheim’s Pradaxa available in UK for DVT

15-07-2014

German family-owned drug major Boehringer Ingelheim says that Pradaxa (dabigatran etexilate) will be…

Boehringer IngelheimDeep vein thrombosisHematologyPharmaceuticalPradaxaRegulationUK

Mylan launches generic Micardis in USA

Mylan launches generic Micardis in USA

08-07-2014

US generic drugmaker Mylan has launched Telmisartan Tablets USP, 20mg, 40mg and 80mg, the generic version…

Boehringer IngelheimCardio-vascularGenericsMarkets & MarketingMicardisMylanRegulationTelmisartanUSA

FDA accepts Boehringer’s nintedanib NDA; granted priority review for IPF

FDA accepts Boehringer’s nintedanib NDA; granted priority review for IPF

02-07-2014

The US subsidiary of German family-owned drug major Boehringer Ingelheim says that the New Drug Application…

Boehringer IngelheimnintedanibPharmaceuticalRegulationRespiratory and PulmonaryUSA

Boehringer submits tiotropium + olodaterol Respimat for European approval in COPD

Boehringer submits tiotropium + olodaterol Respimat for European approval in COPD

02-07-2014

German family-owned pharma major Boehringer Ingelheim says it has submitted Marketing Authorization Applications…

Boehringer IngelheimEuropePharmaceuticalRegulationRespiratory and Pulmonarytiotropium + olodaterol Respimat

FDA Breakthrough status for Boehringer’s investigational Pradaxa antidote

FDA Breakthrough status for Boehringer’s investigational Pradaxa antidote

26-06-2014

The US Food and Drug Administration has granted Breakthrough Therapy designation to idarucizumab, an…

Boehringer IngelheimCardio-vascularidarucizumabPharmaceuticalPradaxaRegulationResearchUSA

Boehringer Ingelheim pulls out of hepatitis C drug development

Boehringer Ingelheim pulls out of hepatitis C drug development

23-06-2014

German family-owned pharma major Boehringer Ingelheim revealed that, following a re-evaluation of its…

Anti-viralsBoehringer IngelheimfaldaprevirPharmaceuticalRegulationResearch

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

Boehringer’s Pradaxa gains added indication in Europe

Boehringer’s Pradaxa gains added indication in Europe

06-06-2014

German family-owned pharma major Boehringer Ingelheim said today that its blood thinner Pradaxa (dabigatran…

Boehringer IngelheimCardio-vascularEuropePharmaceuticalPradaxaRegulation

EMA accepts Boehringer’s accelerated marketing application for nintedanib in IPF

EMA accepts Boehringer’s accelerated marketing application for nintedanib in IPF

05-06-2014

German family-owned pharma major Boehringer Ingelheim said this morning that the European Medicines Agency…

Boehringer IngelheimEuropenintedanibPharmaceuticalRegulationRespiratory and Pulmonary

Boehringer resolves FDA manufacturing facility concerns

Boehringer resolves FDA manufacturing facility concerns

03-06-2014

German family-owned pharma major Boehringer Ingelheim said today that it has been notified by a letter…

Boehringer IngelheimFood and Drug AdministrationGermanyPharmaceuticalPharmaceutical sciencesProductionRegulationResearchUSA

Boehringer and Lilly’s diabetes drug Jardiance gains EU approval

23-05-2014

German family-owned pharma major Boehringer Ingelheim and US partner Eli Lilly have received Marketing…

Boehringer IngelheimDiabetesEli LillyempagliflozinEuropeJardiancePharmaceuticalRegulation

FDA finds favorable risk:benefit balance for Boehringer’s Pradaxa

18-05-2014

As part of its ongoing review, the US Food and Drug Administration last week released latest findings…

Boehringer IngelheimCardio-vascularPharmaceuticalPradaxaRegulationUSA

UK NICE recommends Giotrif and Velcade, but says “no” to added use of Alimta

23-04-2014

People in England and Wales with lung cancer whose tumors test positive for a mutation will now have…

AlimtaBoehringer IngelheimEli LillyGiotrifJohnson & JohnsonNorthern EuropeOncologyPharmaceuticalPricingRegulationUKVelcade

NDA filing for empagliflozin and linagliptin combo accepted by FDA

NDA filing for empagliflozin and linagliptin combo accepted by FDA

14-04-2014

The US Food and Drug Administration has accepted the filing of the New Drug Application for the investigational…

Boehringer IngelheimDiabetesEli LillyempagliflozinJardiancelinagliptinNorth AmericaPharmaceuticalRegulationTradjentaUSA

US FDA clears Boehringer Ingelheim’s Pradaxa for additional indications

US FDA clears Boehringer Ingelheim’s Pradaxa for additional indications

07-04-2014

The US Food and Drug Administration has approved German family-owned pharma major Boehringer Ingelheim’s…

Boehringer IngelheimCardio-vascularNorth AmericaPharmaceuticalPradaxaRegulationUSA

EMA/CHMP recommends empagliflozin for approval for type 2 diabetes

23-03-2014

German family-owned drug major Boehringer Ingelheim and partner Eli Lilly of the USA have announce a…

Boehringer IngelheimDiabetesEli LillyempagliflozinEuropeJardiancePharmaceuticalRegulation

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