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...
FDA commissioner Marty Makary says the agency will improve the communication channels between reviewers and companies to help speed innovation and med...
FDA says it has made labeling changes to fenofibrates as requested in a Healthy Women petition and does not see a need for additional communications s...
Based on safety concerns, FDA places a clinical hold on Gileads HIV treatment trials of GS-1720, an investigational integrase strand transfer inhibito...
