Regulation - Nephrology and Hepatology, Neurological

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More November EMA/CHMP recommendations

22-11-2014

A total of 10 new medicines have been recommended for approval at the November 2014 meeting of the European…

apremilastBoehringer IngelheimCelgene Corp.DermatologicalsEuropeNephrology and HepatologyNeurologicalnintedanibOfevOtezlaPharmaceuticalRasagilineRegulationRespiratory and PulmonarySanofiShionogiTeva Pharmaceutcal Industries

Highlights of EMA Pharmacovigilance committee July meeting

Highlights of EMA Pharmacovigilance committee July meeting

14-07-2014

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) concluded two safety…

bromocriptineEuropeNephrology and HepatologyNeurologicalPharmaceuticalRegulationRiensoTakeda Pharmaceuticalvalproate Sodium InjectionWomen's Health

Positive EU regulatory news for Alexza and Ferrer, but not Gentium

22-02-2013

USA-based Alexza Pharmaceuticals (Nasdaq: ALXA) and Spanish partner Grupo Ferrer Internacional have received…

AdasuveAlexza PharmaceuticalBiotechnologydefibrotideEuropeFerrer InternacionalGentiumNephrology and HepatologyNeurologicalPharmaceuticalRegulation

FDA extends PDUFA date for Biogen Idec's MS drug BG-12; Abbott and Reata's bardoxolone stalled

19-10-2012

Shares of US biotech firm Biogen Idec (Nasdaq: BIIB) fell 3% to $149.50 in premarket trading yesterday,…

Abbott LaboratoriesbardoxoloneBG-12Biogen IdecBiotechnologyDiabetesNephrology and HepatologyNeurologicalNorth AmericaPharmaceuticalReata PharmaceuticalsRegulationResearch

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