MGI Dacogen Launch Plans Stress Efficacy Profile, Treatment Duration
MGI will highlight the efficacy profile of its myelodysplastic syndromes therapy Dacogen when detailing decitabine to oncologists
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FDA's final approval tally of new molecular entities in 2006 is almost a 25-year low, despite early signs that the agency was on pace to best last year's final count of NME approvals
Celgene's Revlimid will launch under the risk management plan RevAssist to minimize fetal exposure, but the firm may lift the program if ongoing studies demonstrate there is no risk of teratogenicity
MGI Pharma expects to file an NDA for Saforis (l-glutamine oral suspension) for the treatment of oral mucositis based on the results of one Phase III trial and supportive earlier-phase trials