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

25-10-2014

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

Baxter InternationalHematologyObizurPharmaceuticalRare diseasesUSA

Novo Nordisk subpoenaed by US Attorney

25-10-2014

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

25-10-2014

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

24-10-2014

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

24-10-2014

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

24-10-2014

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

AbbVieFinancialPharmaceuticalShire

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

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