The Biotechnology Industry Organization says it will use the ViS Research Institute’s online analytics platform to help companies streamline pediatric research.
FDA grants Cubist Pharmaceuticals fast track status for its late-stage antibiotic candidate ceftolozane/tazobactam (CXA-201) for treating various infections.
Endo says its original Opana is so similar to original OxyContin in use and abuse that FDA should determine that Opana was withdrawn for reasons of safety or effectiveness and cannot be referenced in an ANDA.
FDA issues a product safety alert for Covidien Endo GIA Articulating 60-3.5 Surgical Stapler Reloads after they were stolen from the manufacturer before being sterilized.