Clolar Launching For Pediatric ALL; Genzyme, FDA Discussing Adult Studies
Executive Summary
Genzyme will employ a sales force of less than 10 to launch Clolar for pediatric acute lymphoblastic leukemia in January
You may also be interested in...
Clolar Confirmatory Study Should Be In Early-Relapse Patients, Cmte. Says
Genzyme's confirmatory study for Clolar should be conducted in an early-relapse leukemia pediatric population, members of the Oncologic Drugs Advisory Committee Pediatric Subcommittee said Oct. 20
Clolar Confirmatory Study Should Be In Early-Relapse Patients, Cmte. Says
Genzyme's confirmatory study for Clolar should be conducted in an early-relapse leukemia pediatric population, members of the Oncologic Drugs Advisory Committee Pediatric Subcommittee said Oct. 20
Accelerated Approval Requests Based On Low Efficacy Frustrate FDA
FDA appears to be increasingly frustrated with sponsors who seek accelerated approval based upon the lowest possible efficacy standard