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Acambis announced that its investigational single-dose vaccine against Japanese encephalitis (JE), ChimeriVax-JE, has met and exceeded the primary immunogenicity endpoint in a pivotal Phase III efficacy trial.
InterMune has discontinued its Phase III INSPIRE clinical trial evaluating Actimmune in patients with idiopathic pulmonary fibrosis (IPF) based on the recommendation of the study's independent data monitoring committee (DMC).
Strides Arcolab has received tentative approval from the FDA for its HIV drug regimen consisting of lamivudine/zidovudine 150-mg/300-mg tablets co-packaged with nevirapine 200-mg tablets, the company announced.
Astellas announced that the FDA has approved Vaprisol, an arginine vasopressin receptor antagonist, for the intravenous treatment of hypervolemic hyponatremia in hospitalized patients.
Dendreon announced that the FDA's Cellular, Tissue and Gene Therapies Advisory Committee will review the company's biologics license application (BLA) for Provenge (sipuleucel-T), an investigational active cellular immunotherapy for the treatment of asymptomatic, metastatic, androgen-independent prostate cancer March 29.
Merck has been told by the FDA that its new drug application (NDA) for Arcoxia (etoricoxib) will be reviewed by the agency's Arthritis Advisory Committee April 12.
New preclinical and clinical trial data show, for the first time, that GlaxoSmithKline's (GSK) candidate prepandemic split-antigen H5N1 vaccine provides a substantial level of cross-immunity against a "drifted" strain of H5N1, the company announced.
TorreyPines Therapeutics has initiated a second Phase I clinical trial of NGX426, a novel product candidate intended to treat chronic pain conditions such as migraine and neuropathic pain.