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Dyax has received guidance in a recent meeting with the FDA's Center for Drug Evaluation and Research, Division of Pulmonary and Allergy Products, regarding the pathway for a biologics license application submission and approval of DX-88 (ecallantide), an orphan drug candidate for treatment of acute attacks of hereditary angioedema.
GlaxoSmithKline (GSK) and Adolor announced results from two Phase III registration studies (012 and 013) of Entereg/Entrareg (alvimopan) for the treatment of opioid-induced bowel dysfunction in patients with chronic non-cancer pain.
Mylan Laboratories announced that the FDA has granted tentative approval for its abbreviated new drug application for fluoxetine capsules, 10 mg and 20 mg.
The European Commission has approved Novartis' Exjade (deferasirox) to treat patients with transfusional iron overload in all 25 member states of the European Union (EU).