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FDA approves Baxter’s new treatment for rare form of hemophilia


The US Food and Drug Administration on Friday approved Obizur (antihemophilic Factor [recombinant), porcine…

Baxter InternationalHematologyObizurPharmaceuticalRare diseasesUSA

Novo Nordisk subpoenaed by US Attorney


Danish diabetes care giant Novo Nordis on Friday revealed it had been served with a subpoena by the office…

DenmarkDiabetesLegalNovo NordiskPharmaceuticalProductionUSA

FDA requests CMC data on Lundbeck’s Carbella application


Danish CNS drug specialist Lundbeck says that it has received a Complete Response Letter (CRL) from the…

CarbamazepineCarbellaLigand PharmaceuticalsLundbeckNeurologicalPharmaceuticalRegulationUSA

Scenesse recommended for rare disease by EMA/CHMP


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

Clinuvel PharmaceuticalsEuropePharmaceuticalRare diseasesRegulationScenesse

EMA calls for strengthened warnings for Iclusig


The European Medicines Agency has concluded its review of the benefits and risks of Iclusig (ponatinib),…

Ariad PharmaceuticalsEuropeIclusigOncologyPharmaceuticalRegulation

Shire posts sharp rises in sales and earnings for third-qtr


Ireland-headquartered Shire has delivered a strong set of financials for the third-quarter of 2014, validating…


AstraZeneca’s Lynparza backed for approval by EMA committee


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


Most-used agents in US bipolar disorder treatment sector; report


Through analysis of US longitudinal patient-level claims data, Bristol-Myers Squibb and Otsuka’s Abilify…

AbilifyBristol-Myers SquibbCymbaltaDainippon Sumitomo PharmaEli LillyGlaxoSmithKlineLamotrigineLatudaMarkets & MarketingNeurologicalOtsukaPharmaceuticalUSA

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