CymaBay Therapeutics terminates a Phase 2b study of seladelpar in subjects with non-alcoholic steatohepatitis and its recently initiated Phase 2 study...
Federal Register notice: CDRH announces an Ethylene Oxide Sterilization Master File Pilot Program that will allow sterilization providers to submit a ...
Federal Register notice: FDA makes available a guidance entitled Compliance Policy for Limited Modifications to Certain Marketed Tobacco Products.
FDA approves a Tusker Medical PMA for the Tubes Under Local Anesthesia System for delivery of tympanostomy tubes (ear tubes) that can be inserted into...
Reps. Upton and DeGette start a process to improve the 21st Century Cures Act.
FDA releases its latest batch of Warning Letters that includes EPH Technologies and Lohxa.
As families sit down for Thanksgiving meals, the Alliance for a Stronger FDA says consideration should be given to FDA staff for their work in assurin...
University of Tokyo researchers say that adverse events reports submitted to FDA vary in completeness depending on the occupation of the person submit...