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In 2014, FDA approved highest number of new drugs in 18 years

In 2014, FDA approved highest number of new drugs in 18 years

04-01-2015

The US Food and Drug Administration's Center for Drug Evaluation and Research approved 41 novel medicines…

AstraZenecaGilead SciencesPharmaceuticalRegulationUSA

AstraZeneca’s Lynparza gains FDA approval

AstraZeneca’s Lynparza gains FDA approval

20-12-2014

The US Food and Drug Administration has granted accelerated approved for Anglo-Swedish drug major AstraZeneca’s…

AstraZenecaLynparzaOncologyPharmaceuticalRegulationUSA

European Commission grants marketing authorization to AstraZeneca's Lynparza

European Commission grants marketing authorization to AstraZeneca's Lynparza

18-12-2014

Anglo-Swedish drug major AstraZeneca has received marketing authorization from the European Commission…

AstraZenecaLynparzaOncologyPharmaceuticalRegulation

AstraZeneca’s Moventig gains EU approval for OIC

09-12-2014

The European Commission has granted marketing authorization for Anglo-Swedish pharma major AstraZeneca’s…

AstraZenecaEuropeGastro-intestinalsMoventigNektar TherapeuticsPharmaceuticalRegulation

FDA advisory panel backs Actavis’ ceftazidime-avibactam

06-12-2014

Ireland-headquartered generic drugs major Actavis says that the Anti-Infective Drugs Advisory Committee…

ActavisAntibiotics and Infectious diseasesAstraZenecaceftazidime-avibactamPharmaceuticalRegulationUSA

FDA accepts NDA filing from AstraZeneca for Iressa

FDA accepts NDA filing from AstraZeneca for Iressa

02-12-2014

The US Food and Drug Administration has accepted for filing the New Drug Application from Iressa (gefitinib)…

AstraZenecaIressaOncologyPharmaceuticalRegulationUK

AstraZeneca’s Duaklir Genuair approved in the EU for COPD

AstraZeneca’s Duaklir Genuair approved in the EU for COPD

25-11-2014

The European Commission has granted marketing authorization for Anglo-Swedish pharma major AstraZeneca’s…

AstraZenecaDuaklir GenuairPharmaceuticalRegulationRespiratory and PulmonaryUK

SMC accepts Eylea and Onglyza for use in NHS Scotland

SMC accepts Eylea and Onglyza for use in NHS Scotland

13-11-2014

The Scottish Medicines Consortium (SMC) has accepted German drugmaker Bayer’s Eylea (aflibercept solution…

AstraZenecaBayerDiabetesEyleaOnglyzaPharmaceuticalRegulationUK

US FDA approves AstraZeneca’s Xigduo XR

US FDA approves AstraZeneca’s Xigduo XR

30-10-2014

The US Food and Drug Administration has approved Anglo-Swedish pharma major AstraZeneca’s once-daily…

AstraZenecaDiabetesPharmaceuticalRegulationUSAXigduo XR

AstraZeneca’s Lynparza backed for approval by EMA committee

AstraZeneca’s Lynparza backed for approval by EMA committee

24-10-2014

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a…

AstraZenecaEuropeLynparzaolaparibOncologyPharmaceuticalRegulation

Brilinta preferred over clopidogrel in latest AHA/ACC guideline

Brilinta preferred over clopidogrel in latest AHA/ACC guideline

06-10-2014

Anglo-Swedish pharma major AstraZeneca today confirmed that the American Heart Association (AHA) and…

AstraZenecaBrilintaCardio-vascularClopidogrelDaiichi SankyoEli LillyPharmaceuticalprasugrelRegulationSanofiticagrelorUSA

Almirall’s aclidinium bromide/formoterol backed by EMA/CHMP to treat COPD

Almirall’s aclidinium bromide/formoterol backed by EMA/CHMP to treat COPD

26-09-2014

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a…

aclidiniumAlmirallAstraZenecaBrimica GenuairDuaklir GenuairEuropeformoterolPharmaceuticalRegulationRespiratory and Pulmonary

FDA approves AstraZeneca’s Movantik for opioid-induced constipation

FDA approves AstraZeneca’s Movantik for opioid-induced constipation

17-09-2014

The US Food and Drug Administration yesterday approved Movantik (naloxegol), an oral treatment for opioid-induced…

AstraZenecaGastro-intestinalsMovantikNektar TherapeuticsPharmaceuticalRegulationUSA

NICE comes back with different views on Tarceva and Iressa for NSCLC

NICE comes back with different views on Tarceva and Iressa for NSCLC

07-08-2014

UK health costs watchdog the National Institute for Health and Care Excellence (NICE) is consulting again…

AstraZenecaIressaOncologyPharmaceuticalPricingRegulationRocheTarcevaUK

Negative view from FDA advisory for AstraZeneca’s olaparib

Negative view from FDA advisory for AstraZeneca’s olaparib

26-06-2014

There was disappointment for Anglo-Swedish pharma major AstraZeneca yesterday when a US Food and Drug…

AstraZenecaLynparzaolaparibOncologyPharmaceuticalRegulationUSA

Positive US FDA advisory panel view on PAMORAs

Positive US FDA advisory panel view on PAMORAs

13-06-2014

The majority of US Food and Drug Administration Anesthetic and Analgesic Drug Products Advisory Committee…

AstraZenecaGastro-intestinalsMovantiknaloxegolPharmaceuticalRegulationUSA

Negative IQWiG view on AstraZeneca’s combo diabetes drug Xigduo

16-05-2014

In an early benefit assessment under the German Act on the Reform of the Market for Medicinal Products…

AstraZenecaDiabetesGermanyPharmaceuticalPricingRegulationXigduo

US FDA approval for AstraZeneca’s Epanova

US FDA approval for AstraZeneca’s Epanova

06-05-2014

There was good news today for Anglo-Swedish drug major AstraZeneca, as the US Food and Drug Administration…

AstraZenecaCardio-vascularEpanovaLovazaPharmaceuticalRegulationUSAVascepa

US FDA grants priority review for AstraZeneca’s olaparib

US FDA grants priority review for AstraZeneca’s olaparib

30-04-2014

The US Food and Drug Administration has granted Priority Review for Anglo-Swedish drug major AstraZeneca’s…

AstraZenecaolaparibOncologyPharmaceuticalRegulationUK

Japanese approval for Forxiga and Lonsurf

24-03-2014

Anglo-Swedish drug major AstraZeneca says that Japanese Ministry of Health, Labor and Welfare approved…

Asia-PacificAstraZenecaDiabetesForxigaJapanLonsurfOncologyOno PharmaceuticalOtsukaPharmaceuticalRegulationTaiho Pharmaceutical

AstraZeneca’s diabetes drug Xigduo launched in UK

AstraZeneca’s diabetes drug Xigduo launched in UK

11-03-2014

Anglo-Swedish drug major AstraZeneca’s type 2 diabetes drug Xigduo is now available in the UK.

AstraZenecaDiabetesPharmaceuticalRegulationUKXigduo

FDA approves Bydureon Pen for type 2 diabetes

FDA approves Bydureon Pen for type 2 diabetes

03-03-2014

Anglo-Swedish drug major AstraZeneca says the US Food and Drug Administration has approved the Bydureon…

AlkermesAmylinAstraZenecaBristol-Myers SquibbBydureonDiabetesPharmaceuticalRegulationUSA

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

Positive CHMP opinion for Teva’s DuoResp Spiromax for asthma and COPD

22-02-2014

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive…

AstraZenecaDuoResp SpiromaxPharmaceuticalRegulationRespiratory and PulmonarySymbicortTeva Pharmaceutical Industries

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