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...
The CDER Office of Prescription Drug Promotion warns Sprout Pharmaceuticals about a social media post for its Addyi that does not include any risk inf...
Due to contamination concerns, Church & Dwight recalls all lots of Zicam Cold Remedy Nasal Swabs, Zicam Nasal AllClear Swabs, and Orajel Baby Teething...
FDA warns Boca Raton, FL-based American Behavioral Research Institute that it did not have an IND for a clinical study of Relaxium.
U.S. and Canadian AI researchers call on FDA to develop a more comprehensive regulatory framework for AI healthcare tools.
