FDA granted a Rare Pediatric Disease Designation to ABT-414, an investigational antibody drug conjugate targeting the epidermal growth factor receptor for the treatment of pediatric patients with EGFR-amplified Diffuse Intrinsic Pontine Glioma, known to be highly aggressive and difficult to treat brain tumors found at the base of the brain. According to AbbVie, the drug’s...
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.
