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Actavis receives final FDA approval for generic version of Subutex

Actavis receives final FDA approval for generic version of Subutex

22-02-2015

Ireland-headquartered generics major Actavis has received final approval from the US Food and Drug Administration…

Abbreviated New Drug ApplicationGenericsIndiviorNeurologicalRC PharmaceuticalsReckitt BenckiserRegulationSubutexUSA

NICE final draft guidance recommends Norgine's Targaxan

NICE final draft guidance recommends Norgine's Targaxan

19-02-2015

The UK’s National Institute for Health and Care Excellence has published its final draft guidance recommending…

Nephrology and HepatologyNeurologicalNorginePharmaceuticalRegulationTargaxanUK

UPDATE: FDA approves Eisai’s Lenvima for a type of thyroid cancer and expands use of Banzel

UPDATE: FDA approves Eisai’s Lenvima for a type of thyroid cancer and expands use of Banzel

14-02-2015

The US Food and Drug Administration on Friday granted approval for Japanese pharma major Eisai’s Lenvima…

BanzelEisailenvatinibLenvimaNeurologicalOncologyPharmaceuticalRare diseasesRegulationUSA

Tecfidera, first-line oral treatment for multiple sclerosis, approved in India

13-02-2015

US biotech major Biogen Idec’s Indian subsidiary has received approval of the first oral therapy for…

Biogen IdecBiotechnologyIndiaNeurologicalRegulationTecfidera

Shire’s Vyvanse first FDA-approved drug for binge eating

Shire’s Vyvanse first FDA-approved drug for binge eating

31-01-2015

The US Food and Drug Administration on Friday approved UK drugmaker Shire’s Vyvanse (lisdexamfetamine…

NeurologicalPharmaceuticalRegulationShireUSAVyvanse

Shire receives fast-track designation from FDA for SHP609 in Hunter syndrome

Shire receives fast-track designation from FDA for SHP609 in Hunter syndrome

27-01-2015

Ireland-headquartered drugmaker Shire has received fast-track designation from the US Food and Drug Administration…

NeurologicalPharmaceuticalRegulationShireSHP609

US and EU regulatory filings for UCB’s antiepileptic brivaracetam

US and EU regulatory filings for UCB’s antiepileptic brivaracetam

21-01-2015

Belgium’s largest pharma company UCB today announced regulatory filings in the USA and the European…

BRIVARACETAMEuropeNeurologicalPharmaceuticalRegulationUCBUSA

US FTC approves final order preserving in nicotine patches market competition

US FTC approves final order preserving in nicotine patches market competition

21-01-2015

Following a public comment period, the USA’s Federal Trade Commission has approved a final order settling…

GlaxoSmithKlineHabitrolMergers & AcquisitionsNeurologicalNovartisPharmaceuticalRegulationUSA

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