Federal Register notice: FDA makes available two draft guidances entitled In Vitro Metabolism- and Transporter-Mediated Drug-Drug Interaction Studies ...
FDA approves an Alexion Pharmaceuticals supplemental BLA for Soliris (eculizumab) as a treatment for adult patients with generalized myasthenia gravis...
FDA Oncology Center of Excellence staff outlines steps to promote greater use of real-world evidence in cancer trials.
Washington Legal Foundation chief counsel Richard Samp criticizes a Third Circuit Court of Appeals decision in a Lipitor patent settlement case.
A U.S. Chamber report outlines steps, including by FDA, that can be taken to restrict lawsuit advertising that it says can harm public health.
FDA clears a RadiaDyne 510(k) for two new indications for its OARtrac radiation dose monitoring platform.
FDA commissioner Scott Gottlieb outlines the agencys efforts as part of HHS to address the nations opioid crisis.
FDA sends PTC Therapeutics a complete response letter for its NDA for ataluren for treating nonsense mutation dystrophinopathies.