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.
FDA commissioner Martin Makary and CBER director Vinay Prasad use a JAMA article to list their five priorities for what they call a new FDA.
Insmed releases positive results from a Phase 2b clinical trial of its once-daily inhaled therapy treprostinil palmitil inhalation powder and its use ...
