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FDA approves Myalept, the first drug to treat a rare metabolic disease

FDA approves Myalept, the first drug to treat a rare metabolic disease

26-02-2014

The US Food and Drug Administration has approved Myalept (metreleptin for injection) as replacement therapy…

AstraZenecaBristol-Myers SquibbmetreleptinMyaleptNorth AmericaPharmaceuticalRare diseasesRegulationUSA

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

Amneal debuts generic Esomeprazole strontium in USA

07-01-2014

Privately-held US generics drugmaker Amneal Pharmaceuticals has announced the launch of generic esomeprazole…

Amneal PharmaAstraZenecaEsomeprazole MagnesiumGastro-intestinalsGenericsMarkets & MarketingNexiumNorth AmericaUSA

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

Mixed FDA advisory panel votes on Bristol-Myers and AstraZeneca's metreleptin

Mixed FDA advisory panel votes on Bristol-Myers and AstraZeneca's metreleptin

12-12-2013

In an 11 to one vote yesterday, the US Food and Drug Administration’s Endocrinologic and Metabolic…

AstraZenecaBristol-Myers SquibbMetabolicsmetreleptinNorth AmericaPharmaceuticalRare diseasesRegulation

AstraZeneca wins damages from Apotex

AstraZeneca wins damages from Apotex

04-12-2013

Anglo-Swedish drug major AstraZeneca this morning said it welcomed the US District Court for the Southern…

ApotexAstraZenecaFinancialGastro-intestinalsGenericsNexium I.V.North AmericaPatentsPrilosec

Horizon Pharma gets US rights for Vimovo from AstraZeneca

Horizon Pharma gets US rights for Vimovo from AstraZeneca

19-11-2013

USA-based Horizon Pharma has entered into an agreement to acquire from Anglo-Swedish drug major AstraZeneca…

Anti-Arthritics/RheumaticsAstraZenecaHorizon PharmaLicensingNorth AmericaPharmaceuticalPozenVimovo

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