Federal Register notice: FDA announces a 6/20 Endocrinologic and Metabolic Drugs Advisory Committee meeting to discuss a supplemental NDA for Novo Nor...
Federal Register notice: FDA seeks comments on an information collection extension on Prescription Drug Advertisements; OMB Control Number 09100686....
A 5/24 FDA Oncologic Drugs Advisory Committee plans to discuss agency concerns over uncertainty in the magnitude of treatment effect due to unplanned ...
FDA warns drug manufacturers of non-sterile, water-based drug products that there have been the subject of recent product recalls due to Burkholderia ...
FDA expands the approved use of Hoffman La Roches subcutaneous Actemra (tocilizumab) to treat adults with giant cell arteritis.
Celgene says its Phase 3 RADIANCE trial met its primary endpoint in evaluating the efficacy and safety of ozanimod in patients with relapsing multiple...
An ongoing FDA review of the risk of brain deposits following repeated use of gadolinium-based contrast agents for MRIs identifies no adverse health e...
Respironics begins a Class 1 recall of its V60 Non-invasive Ventilator because the pins within the internal cable that connects the ventilator's motor...