Regulation - Boehringer Ingelheim, North America


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US FDA clears Boehringer Ingelheim’s Pradaxa for additional indications

US FDA clears Boehringer Ingelheim’s Pradaxa for additional indications


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

Boehringer IngelheimCardio-vascularNorth AmericaPharmaceuticalPradaxaRegulationUSA

FDA issues CRL on empagliflozin, noting manufacturing deficiencies

FDA issues CRL on empagliflozin, noting manufacturing deficiencies


There was disappointment today for US drug major Eli Lilly and family-owned German pharma firm Boehringer…

Boehringer IngelheimDiabetesEli LillyempagliflozinNorth AmericaPharmaceuticalProductionRegulationUSA

Pradaxa sNDA for DVT and PE accepted by FDA


The US Food and Drug Administration has accepted for review German independent drug major Boehringer…

Boehringer IngelheimCardio-vascularNorth AmericaPharmaceuticalPradaxaRegulation

US FDA approves Boehringer Ingelheim's first cancer drug


In what the family-owned German drug major Boehringer Ingelheim hopes is just the first drug to come…

afatinibBiotechnologyBoehringer IngelheimGilotrifNorth AmericaOncologyPharmaceuticalQiagenRegulation

FDA approves Boehringer and Lilly's Tradjenta and Jentadueto labeling to reflect pancreatitis risk


German family-owned Boehringer Ingelheim and US partner Eli Lilly (NYSE: LLY) revealed yesterday (June…

Boehringer IngelheimDiabetesEli LillyJentaduetoNorth AmericaPharmaceuticalRegulationTradjenta

SOBI gets FDA approval to manufacture substance for Kineret with partner Boehringer Ingelheim


Swedish Orphan Biovitrum (STO: SOBI) said today (June 11) that it has received approval from the US Food…

Boehringer IngelheimInflammatory diseasesKineretNorth AmericaPharmaceuticalProductionRegulationSavient PharmaceuticalsSwedish Orphan Biovitrum

Gilead gains FDA priority review for hep C candidate sofosbuvir; new data on Boehringer's faldaprevir


US biotech firm Gilead Sciences (Nasdaq: GILD) revealed on Friday (June 7) that the US Food and Drug…

Anti-viralsAsia-PacificBiotechnologyBoehringer IngelheimfaldaprevirGilead SciencesNorth AmericaPharmaceuticalRegulationResearchsofosbuvir

US FDA approves companion diagnostic for Tarceva, and new indication for the Roche drug


The US Food and Drug Administration late yesterday (May 14) approved Swiss drug major Roche (ROG: SIX)…

Boehringer IngelheimNorth AmericaOncologyPharmaceuticalQiagenRegulationRocheTarcevaTomtovok

Regulatory briefs on Bayer's Stivarga, Boehringer/Lilly's empagliflozin and Pfizer's Xeljanz


Drug regulator Health Canada has approved German drug major Bayer's Stivarga (regorafenib tablets), indicated…

Anti-Arthritics/RheumaticsAsia-PacificBayerBiotechnologyBoehringer IngelheimDiabetesEli LillyempagliflozinNorth AmericaOncologyPfizerPharmaceuticalRegulationStivargaXeljanz

FDA probes possible higher risk of pancreatitis for newer type 2 diabetes drugs


The US Food and Drug Administration revealed in a web posting yesterday that it is evaluating unpublished…

Boehringer IngelheimBristol-Myers SquibbDiabetesEli LillyExenatide InjectionlinagliptinMerck & CoNorth AmericaNovo NordiskPharmaceuticalRegulationsaxagliptinsitagliptinVictoza

FDA advisory panel backs Boehringer's COPD drug olodaterol


In a 15 to one vote with one abstension, the US Food and Drug Administration's Pulmonary-Allergy Drugs…

Boehringer IngelheimNorth AmericaolodaterolPharmaceuticalRegulationRespiratory and PulmonaryStriverdi Respimat

Boehringer Ingelheim's afatinib NDA gets priority review in USA


The US subsidiary of German independent drug major Boehringer Ingelheim revealed yesterday that the New…

afatinibBoehringer IngelheimNorth AmericaOncologyPharmaceuticalQiagenRegulationTomtovok

Boehringer Ingelheim updates safety info for Pradaxa related to heart valve


The US subsidiary of German independent drug major Boehringer Ingelheim says that the US prescribing…

Boehringer IngelheimCardio-vascularNorth AmericaPharmaceuticalPradaxaRegulation

Serious bleeding risk with Boehringer's Pradaxa no worse than warfarin, says FDA


In a follow up to a 2011 safety communication, the US Food and Drug Administration has evaluated new…

Boehringer IngelheimCardio-vascularNorth AmericaPharmaceuticalPradaxaRegulationResearch

FDA approves expanded use of Boehringer and Lilly's Tradjenta


German family-owned drug major Boehringer Ingelheim and US partner and Eli Lilly (NYSE: LLY) said on…

Boehringer IngelheimDiabetesEli LillyNorth AmericaPharmaceuticalRegulationTradjenta

Boehringer Ingelheim updates US labelling of Pradaxa for stroke


Independent German drug major Boehringer Ingelheim has updated the US prescribing information for Pradaxa…

Boehringer IngelheimCardio-vascularNorth AmericaPharmaceuticalPradaxaRegulation

FDA approves combo diabetes drug Jentadueto and Kalydeco


The US Food and Drug Administration) has approved Jentadueto (linagliptin/metformin hydrochloride) tablets,…

Boehringer IngelheimDiabetesEli LillyJentaduetoKalydecolinagliptinNorth AmericaPharmaceuticalRare diseasesRegulationVertex

FDA reviews Pradaxa bleeding risk


Post-marketing reports of serious bleeding events in patients taking Pradaxa (dabigatran etexilate mesylate),…

Boehringer IngelheimCardio-vascularNorth AmericaPharmaceuticalPradaxaRegulation

EMA makes interim recommendations to deal with shortcomings at Ben Venue Labs


The European Medicines Agency (EMA) is currently reviewing shortcomings in quality assurance identified…

Boehringer IngelheimEuropeMarkets & MarketingNorth AmericaPharmaceuticalRegulation

Boehringer Ingelheim’s Combivent Respimat Inhalation Spray OKed in USA to replace aerosol


The US Food and Drug Administration has approved German independent drug major Boehringer Ingelheim’s…

Boehringer IngelheimCombiventNorth AmericaPharmaceuticalRegulationRespiratory and Pulmonary

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