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The approval is based on positive findings from two global Phase 3 studies in which Kalydeco demonstrated significant improvements in breathing, weight gain and other measures of disease

The randomised, double-blind, parallel-group study designed to assess the efficacy of treatment with Actemra 162mg SC given every two weeks versus placebo given every two weeks, both in

With the satisfactory closure of observations in the warning letter and the lifting of the import alert, Dr. Reddy’s can start importing products to the US from the

The generic Sporanox is indicated for the treatment of fungal infections that begin in the lungs, blatsomycosis, histoplasmosis, and aspergillosis in patients who are intolerant of or who

ARISg and ARISj solutions are designed for collecting, assessing, distributing and managing adverse event reporting requirements of different authorities from case entry to automatic generation of submission-ready adverse

The open-label, multicenter extension study was designed to evaluate the safety and efficacy of Cinryze and involved 146 HAE subjects, who were treated for up to 2.6 years

The resubmission of NDAs is in response to a complete response letter received by Takeda from the FDA on 25 April 2012. The resubmissions include additional data from

The randomized, multiple-dose study enroled a total of 37 patients who had active RA on methotrexate in four dose-escalating cohorts ranging from 0.15ug/kg to 1.50ug/kg of PRTX-100 or

The $582,473 grant will fund research to develop Biodel’s ultra-rapid-acting insulin product candidate at high concentrations suited to provide sufficient quantities of insulin in an external artificial pancreas