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Cephalon announced it has received an approvable letter, together with draft labeling, from the FDA for its new drug application (NDA) for Nuvigil for the treatment of excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome and shift-work sleep disorder.
Myriad Genetics announced it has initiated a Phase II human clinical trial of its therapeutic candidate Azixa in patients with melanoma that has spread to the brain.
Helix BioPharma has announced positive results from a Phase II clinical study of its topical interferon alpha-2b in women with low-grade cervical lesions caused by human papillomavirus (HPV).
GlaxoSmithKline (GSK) announced it has submitted a biologics license application (BLA) for its human papillomavirus (HPV) vaccine, Ceravix, to the FDA.
Dendreon announced that the FDA's Cellular, Tissue and Gene Therapies Advisory Committee recommended to the FDA that there is substantial evidence of the efficacy and safety of Provenge as a treatment for patients with asymptomatic, metastatic, androgen-independent (also known as hormone-refractory) prostate cancer.
Medarex has announced that Valortim, a fully human monoclonal antibody product candidate being developed for the prevention and treatment of anthrax infection, has been shown to have a therapeutic effect in a new primate model of established inhalation anthrax infection.