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FDA delays approval of Biogen Idec’s MS drug Plegridy

FDA delays approval of Biogen Idec’s MS drug Plegridy

18-03-2014

The US Food and Drug Administration has extended the initial Prescription Drug User Fee Act date for…

Biogen IdecBiotechnologyNeurologicalNorth AmericaPlegridyRegulationUSA

US FDA delays Alprolix approval

US FDA delays Alprolix approval

02-12-2013

The US Food and Drug Administration (has extended the initial Prescription Drug User Fee Act date for…

AlprolixBiogen IdecBiotechnologyHematologyNorth AmericaRegulationSwedish Orphan BiovitrumUSA

2013 FDA approval rates suggest record year for post-launch success

14-11-2013

A focus on hard to treat or specialist diseases is set to result in record post-launch sales for new…

Biogen IdecFinancialGilead SciencesNorth AmericaPharmaceuticalRegulationsofosbuvirTecfidera

Biogen and SOBI announce top line results for hemophilia A treatment Eloctate

Biogen and SOBI announce top line results for hemophilia A treatment Eloctate

14-11-2013

US biotech major Biogen Idec (Nasdaq: BIIB) and Swedish Orphan Biovitrum (STO: SOBI) have announced detailed…

Biogen IdecBiotechnologyEloctateHematologyNorth AmericaResearchSobiUSA

US FDA calls for further data on Biogen Idec’s Eloctate

US FDA calls for further data on Biogen Idec’s Eloctate

13-11-2013

Swedish Orphan Biovitrum has announced that its partner, US biotech major Biogen Idec, has received a…

Biogen IdecBiotechnologyEloctateHematologyNorth AmericaRegulationSwedish Orphan Biovitrum

Roche’s Gazyva gains FDA approval of CLL

Roche’s Gazyva gains FDA approval of CLL

04-11-2013

The US Food and Drug Administration late Friday approved Roche’s Gazyva (obinutuzumab), also known…

Biogen IdecBiotechnologyGazyvaGenentechMabTheraNorth AmericaobinutuzumabOncologyRegulationRituxanRoche

US FDA warns of hepatitis B reactivation risk with Arzerra and Rituxan

US FDA warns of hepatitis B reactivation risk with Arzerra and Rituxan

26-09-2013

The US Food and Drug Administration has approved changes to the prescribing information of the immune-suppressing…

Anti-Arthritics/RheumaticsArzerraBiogen IdecGlaxoSmithKlineNorth AmericaOncologyPharmaceuticalRegulationRituxanRoche

Mixed US views on Gilenya, Aubagio and Tecfidera as breakthrough MS drugs

03-09-2013

More than half of surveyed neurologists consider US biotech firm Biogen Idec's (Nasdaq: BIIB) Tecfidera…

AubagioBiogen IdecGilenyaMarkets & MarketingNeurologicalNorth AmericaNovartisPharmaceuticalPricingSanofiTecfidera

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