Selumetinib was recommended for conditional marketing authorisation in the European Union for the treatment of symptomatic, inoperable plexiform neurofibromas in pediatric patients with neurofibromatosis type 1 aged three years and above.
Last week, Richard Pazdur was named to the position of director of FDA’s Center for Drug Evaluation and Research. Much has been written about how Pazdur, with nearly a three-decade long career at the agency, represents a stabilizing choice for FDA as it faces inner and outer turmoil.
