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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

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

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

Takeda stops development of diabetes candidate fasiglifam; PDUFA date for vedolizumab extended

Takeda stops development of diabetes candidate fasiglifam; PDUFA date for vedolizumab extended

27-12-2013

Japan’s largest drugmaker Takeda Pharmaceutical has decided voluntarily to terminate the development…

DiabetesfasiglifamGastro-intestinalsNorth AmericaPharmaceuticalRegulationResearchTakeda PharmaceuticalsUSAvedolizumab

Novo Nordisk files for approval of high strength liraglutide for obesity

Novo Nordisk files for approval of high strength liraglutide for obesity

22-12-2013

Danish insulin giant Novo Nordisk has filed separate regulatory submissions with the US Food and Drug…

DiabetesEuropeliraglutideMetabolicsNorth AmericaNovo NordiskPharmaceuticalRegulationVictoza

US FDA calls for more data on Janssen’s fixed dose diabetes drug

US FDA calls for more data on Janssen’s fixed dose diabetes drug

16-12-2013

US health care giant Johnson & Johnson has received a complete response letter from the Food and Drug…

canagliflozinDiabetesJanssenJohnson & JohnsonmetforminNorth AmericaPharmaceuticalRegulation

Strong FDA advisory panel backing for Bristol-Myers/AstraZeneca’s diabetes drug

Strong FDA advisory panel backing for Bristol-Myers/AstraZeneca’s diabetes drug

13-12-2013

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

AstraZenecaBristol-Myers SquibbdapagliflozinDiabetesForxigaNorth AmericaPharmaceuticalRegulation

US FDA eases restrictions on GSK diabetes drug Avandia

US FDA eases restrictions on GSK diabetes drug Avandia

26-11-2013

The US Food and Drug Administration yesterday (November 25) lifted some severe limitations on the prescribing…

AvandiaDiabetesGlaxoSmithKlineNorth AmericaPharmaceuticalRegulation

J&J’s Invokana approved in Europe and Olysio cleared in USA

J&J’s Invokana approved in Europe and Olysio cleared in USA

25-11-2013

It was a good news day for US health care giant Johnson & Johnson, with two of its Janssen subsidiaries…

Anti-viralsDiabetesEuropeInvokanaJanssenJohnson & JohnsonMedivirNorth AmericaOlysioPharmaceuticalRegulation

Eylea filed for EU and US approval in diabetic macular edema

Eylea filed for EU and US approval in diabetic macular edema

07-11-2013

US biotech firm Regeneron Pharmaceuticals says its partner German drug major Bayer has submitted an application…

BayerDiabetesEuropeEyleaNorth AmericaOphthalmicsPharmaceuticalRegeneronRegulation

Novo Nordisk gains US FDA approval for FlexTouch insulin pens

Novo Nordisk gains US FDA approval for FlexTouch insulin pens

03-11-2013

Danish insulin giant Novo Nordisk announced on Friday that the US Food and Drug Administration has approved…

DiabetesFlexTouchLevemirNorth AmericaNovo NordiskNovoRapidPharmaceuticalRegulation

MannKind resubmits NDA for diabetes drug Afrezza after positive study results

MannKind resubmits NDA for diabetes drug Afrezza after positive study results

14-10-2013

MannKind has resubmitted its New Drug Application to the FDA for the marketing and sale of Afrezza Inhalation…

AfrezzaBiotechnologyDiabetesMannKindNorth AmericaRegulation

Sanofi temporarily pulls lixisenatide NDA in USA

12-09-2013

French drug major Sanofi (Euronext: SAN) this morning (September 12) announced its decision to withdraw…

DiabeteslixisenatideLyxumiaNorth AmericaPharmaceuticalRegulationSanofiZealand Pharma

Novo Nordisk makes US appointment; gets appro for NovoPen Echo

21-08-2013

Danish insulin giant Novo Nordisk (NOV: N) said late yesterday (August 21) that Jesper Hoiland has been…

DiabetesManagementNorth AmericaNovo NordiskNovoPen EchoPharmaceuticalRegulation

Positive results with MannKind's type 1 diabetes drug please investors

15-08-2013

There was good news for loss-making US drugmaker MannKind (Nasdaq: MNKD), when the company announced…

AfrezzaDiabetesMannKindNorth AmericaPharmaceuticalRegulationResearch

US PDUFA for GSK diabetes drug delayed

03-08-2013

UK pharma giant GlaxoSmithKline (LSE: GSK) revealed on Friday (August 2) that the US Prescription Drug…

albiglutideDiabetesGlaxoSmithKlineNorth AmericaPharmaceuticalRegulation

Tentative FDA clearance for generic copy of Novo Nordisk diabetes product

22-07-2013

US drugmaker Perrigo (Nasdaq: PRGO; TASE) says it has received tentative approval from the US Food &…

DiabetesGenericsNorth AmericaNovo NordiskPerrigoPrandinRegulation

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

Majority vote from FDA advisory panel to ease restrictions on GSK's Avandia

07-06-2013

A joint advisory committee to the US Food and Drug Administration (FDA) voted to continue to make UK…

AvandiaDiabetesGlaxoSmithKlineNorth AmericaPharmaceuticalRegulation

Bristol-Myers gets added indication from US FDA for Sustiva; signs second deal with Ambrx

06-05-2013

US pharma major Bristol-Myers Squibb (NYSE: BMY) says that the US Food and Drug Administration has approved…

AmbrxAnti-viralsBiotechnologyBristol-Myers SquibbCardio-vascularDiabetesLicensingNorth AmericaPharmaceuticalRegulationSustiva

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