ARTICLE | Clinical News
Anthim obiltoxaximab regulatory update
March 28, 2016 7:00 AM UTC
FDA approved a BLA from Elusys for Anthim obiltoxaximab to treat inhalational anthrax in combination with antibacterial drugs and prevent inhalational anthrax when alternative therapies are not available or are inappropriate. Anthim was approved under FDA’s Animal Rule, which allows marketing approval to be granted based on efficacy in relevant animal models and an acceptable safety risk profile in humans. ...