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Eisai announced that its UK subsidiary received a marketing authorization approval for the antiepileptic agent Inovelon (rufinamide) as adjunctive therapy to treat Lennox-Gastaut Syndrome (LGS) in the European Commission.
Barr Pharmaceuticals announced that its subsidiary Pliva has received final approval from the FDA for its abbreviated new drug application to manufacture and market azithromycin for injection, 500 mg.
Ortho Biotech Products announced that the FDA has accepted its application for Doxil (doxorubicin HCl liposome injection) as combination therapy with Velcade (bortezomib) for injection to treat patients with multiple myeloma who have received at least one prior therapy.
Pharmion has submitted a marketing authorization application with the European Medicines Agency for Thalidomide Pharmion for the treatment of untreated multiple myeloma in the European Union.
Novavax's novel virus-like particle (VLP) vaccines have been shown to be effective in generating protection against pandemic influenza as well as cross protection against different strains of the virus in preclinical studies, according to data presented at the Phacilitate Vaccine Forum.
Sequella has received fast-track designation from the FDA for SQ109, the company's proprietary lead drug candidate for treatment of pulmonary tuberculosis (TB).
Coley Pharmaceutical announced it has decided to suspend the development of Actilon, its product candidate for the treatment of hepatitis C virus (HCV) infection.