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Watson Pharmaceuticals announced that it has received final approval from the FDA for its abbreviated new drug application for levonorgestrel/ethinyl estradiol tablets, 0.15 mg/0.03 mg.
Abbott announced it has simultaneously submitted a supplemental biologics license application with the FDA and a Type II Variation to the European Medicines Agency seeking approval to market Humira (adalimumab) as a treatment for moderate-to-severe Crohn's disease.
Introgen Therapeutics announced that Gendux, its wholly owned subsidiary, was notified by the European Medicines Agency Committee for Orphan Medicinal Products that Advexin p53 therapy has received orphan drug designation in Europe for the treatment of Li-Fraumeni syndrome, a genetic disorder characterized by inherited mutations in the p53 tumor suppressor gene.
AlphaVax has presented results from a Phase I trial evaluating a prototype HIV vaccine incorporating the HIV gag gene made using the company's alphavaccine technology.
Rigel Pharmaceuticals has initiated enrollment and dosing in a Phase II study evaluating the efficacy and safety of its lead product candidate, R788, an oral syk kinase inhibitor, for the treatment of patients with rheumatoid arthritis.
Myogen has initiated ARIES-3 (AMB-323), a Phase III long-term, open-label safety and efficacy study of ambrisentan in a broad population of patients with pulmonary hypertension (PH).
Genzyme announced that the first patient has been treated in a new Phase III clinical trial examining the safety and effectiveness of Clolar (clofarabine) in older patients with acute myelogenous leukemia (AML).