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The application seeks to expand the indication for the drug which is currently approved only as a first-line treatment of metastatic colorectal cancer in combination with chemotherapy. The

The drug is currently available in 100, 50, 25 and 12.5mg tablet dosage strengths. The 200mg tablet is a new dosage strength developed by Ivax to create additional

The committee made its recommendation following a planned interim analysis of clinical data from the study in which no safety concerns were identified. The study is expected to

The trial was designed to compare the safety and efficacy of whole brain radiation therapy alone to brain radiation plus Xcytrin. Although patients receiving Xcytrin had a longer

The results demonstrated a dose related increase in cardiac output of up to 40% with only a 6% increase in heart rate. In addition 7 of 8 patients

Earlier this month, Alnylam initiated its first phase I study in Europe and received clearance of its investigational new drug application by the FDA. Respiratory syncytial virus (RSV)

ViaCell intends to submit information to the investigational review boards at each study site involved in the phase I trial to request immediate resumption of. To date, CB001

In the trial, patients treated with the Dynavax vaccine showed 100% seroprotection compared with 90.5% seroprotection in the group treated with the GSK vaccine. Results also showed that

Eisai Medical Research submitted the revised application after the FDA rejected the original filing, submitted in August 2005, due to deficiencies in its format. Aricept, which is co-promoted