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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

MannKind’s diabetes drug Afrezza recommended by FDA advisory

02-04-2014

The US Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee yesterday…

AfrezzaDiabetesMannKindNorth AmericaPharmaceuticalRegulationUSA

FDA issues CRL on empagliflozin, noting manufacturing deficiencies

FDA issues CRL on empagliflozin, noting manufacturing deficiencies

05-03-2014

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

Boehringer IngelheimDiabetesEli LillyempagliflozinNorth AmericaPharmaceuticalProductionRegulationUSA

Nearly 200 new medicines in development for diabetes by US drugmakers

12-02-2014

The USA’s biopharmaceutical research companies are currently developing 180 innovative new medicines…

DiabetesNorth AmericaPharmaceuticalResearch

FDA to review heart failure risk with AstraZeneca diabetes drug

FDA to review heart failure risk with AstraZeneca diabetes drug

12-02-2014

The US Food and Drug Administration has requested clinical trial data from Anglo-Swedish drug major AstraZeneca,…

AstraZenecaDiabetesKombiglyzeNorth AmericaOnglyzaPharmaceuticalRegulationResearchUSA

Sanofi sues Eli Lilly over Lantus patent infringement

Sanofi sues Eli Lilly over Lantus patent infringement

31-01-2014

French drug major Sanofi says it has filed a patent infringement suit against USA pharma firm Eli Lilly…

BiosimilarsDiabetesEli LillyLantusLegalNorth AmericaPatentsPharmaceuticalSanofiUSA

US FDA approves AstraZeneca’s Farxiga to treat type 2 diabetes

US FDA approves AstraZeneca’s Farxiga to treat type 2 diabetes

09-01-2014

Reversing a previous 2012 negative decision, the US Food and Drug Administration yesterday approved Anglo-Swedish…

AstraZenecaBristol-Myers SquibbdapagliflozinDiabetesFarxigaNorth AmericaPharmaceuticalRegulationUSA

DiaVacs' type 1 diabetes drug candidate gains orphan designation from FDA

DiaVacs' type 1 diabetes drug candidate gains orphan designation from FDA

06-01-2014

US clinical-stage biotech firm DiaVacs has granted orphan drug designation for its type 1 diabetes mellitus…

BiotechnologyDiabetesDiaVacsDV-0100North AmericaRegulationUSA

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