FDA grants Sumitomo Pharma America a fast track designation for nuvisertib (TP-3654) and its use in treating patients with intermediate or high-risk m...
Current and former CDC employees rally outside the agencys Atlanta headquarters yesterday over Trump Administration-inspired chaos affecting the healt...
FDA warns Worland, WY-based Amish Origins Management about CGMP violations in its manufacturing of unapproved and misbranded drug products.
FDA publishes statistics on real-world evidence submissions to CBER and CDER in FY 2024 compared to the previous year.
FDA posts an online notice explaining CDERs Bayesian Statistical Analysis demonstration project.
The Federal Trade Commission and Justice Department announce three live-streamed listening sessions on aspects of the effort to cut prescription drug ...
FDA approves an AbbVie expanded label for Mavyret (glecaprevir/pibrentasvir) to include treating adults and pediatric patients three years and older w...
FDA approves a Nuvation Bio NDA for Ibtrozi (taletrectinib), a kinase inhibitor for adults with locally advanced or metastatic ROS1-positive non-small...
