FDA issues a safety update on LivaNovas Stӧckert 3T Heater-Cooler System to help prevent the spread of infection related to the use of the devic...
FDA finalizes two guidances with recommendations on industry communications with payors and other entities.
Based on disappointing data, Eli Lilly and AstraZeneca are discontinue global Phase 3 clinical trials of lanabecestat for treating Alzheimers disease....
FDA warns Taiwans Taiwan Biotech about CGMP violations in its production of finished drugs.
Public Citizen says HHS has made changes to an NIH cardiac trial protocol and consent form to ease ethical concerns raised by the advocacy group.
FDA releases its latest batch of Warning Letters that includes one medical product company Taiwan Biotech Company.
The DC federal court orders FDA to grant orphan drug exclusivity to Eagle Pharmaceuticals Bendeka.
FDA approves Mercks Keytruda (pembrolizumab), an anti-PD-1 therapy for treating patients with recurrent or metastatic cervical cancer with disease pro...