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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

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

Teva gains approval for generic Evista in the USA

Teva gains approval for generic Evista in the USA

04-03-2014

Israel-based Teva Pharmaceutical Industries says it has received approval from the US Food and Drug Administration…

Anti-Arthritics/RheumaticsEli LillyEvistaGenericsNorth AmericaRegulationTeva Pharmaceutical IndustriesUSA

FDA investigating risk of stroke, heart attack and death with testosterone products

FDA investigating risk of stroke, heart attack and death with testosterone products

03-02-2014

The US Food and Drug Administration said on Friday that it is investigating the risk of stroke, heart…

AbbVieActavisAndrodermAndroGelAxironEli LillyMen's HealthNorth AmericaPharmaceuticalRegulationResearchTestosteroneUSA

Actavis confirms challenge of Lilly’s Axiron patent

Actavis confirms challenge of Lilly’s Axiron patent

14-11-2013

US generics major Actavis confirms that it has filed an Abbreviated New Drug Application with the US…

ActavisAxironEli LillyGenericsLegalMen's HealthNorth AmericaPatentsRegulation

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

21-06-2013

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

Boehringer IngelheimDiabetesEli LillyJentaduetoNorth AmericaPharmaceuticalRegulationTradjenta

FDA probes two deaths possibly linked to Lilly's antipsychotic Zyprexa Relprevv

19-06-2013

The US Food and Drug Administration yesterday (June 18) revealed it is investigating two unexplained…

Eli LillyNeurologicalNorth AmericaPharmaceuticalRegulationZyprexa

FDA clears new use for Eli Lilly's Alimta

19-10-2012

US drug major Eli Lilly (NYSE: LLY) says that patients may receive Alimta (pemetrexed for injection)…

AlimtaEli LillyNorth AmericaOncologyPharmaceuticalRegulation

FDA approves expanded use of Boehringer and Lilly's Tradjenta

20-08-2012

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

Boehringer IngelheimDiabetesEli LillyNorth AmericaPharmaceuticalRegulationTradjenta

US FDA approves Erbitux as first-line treatment in KRAS wild-type EGFR

09-07-2012

US drug majors Eli Lilly (NYSE: LLY) and Bristol-Myers Squibb (NYSE: BMY) on Friday received full approval…

Bristol-Myers SquibbEli LillyErbituxNorth AmericaOncologyPharmaceuticalQiagenRegulation

Eli Lilly gains six months US pediatric exclusivity for Cymbalta

08-07-2012

US drug major Eli Lilly (NYSE: LLY) announced that it has met the US Food and Drug Administration requirements…

CymbaltaEli LillyNeurologicalNorth AmericaPharmaceuticalRegulation

FDA approves combo diabetes drug Jentadueto and Kalydeco

01-02-2012

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

Boehringer IngelheimDiabetesEli LillyJentaduetoKalydecolinagliptinNorth AmericaPharmaceuticalRare diseasesRegulationVertex

FDA finally approves Bydureon

30-01-2012

There was good news on Friday for USA-based Amylin Pharmaceuticals (Nasdaq: AMLN) and Alkermes (Nasdaq:…

AlkermesAmylinBydureonDiabetesEli LillyNorth AmericaPharmaceuticalRegulation

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