HHS secretary Robert F. Kennedy, Jr., says FDA is reviewing safety evidence relating to the medication abortion drug mifepristone.
FDA says the Risk Evaluation and Management Strategy program that has been in place since 2011 for Sanofis thyroid cancer drug Caprelsa is no longer n...
FDA warns Dr. Ralph DeFronzo about violations in his work as a clinical investigator for two trial protocols at the University of Texas Health Science...
Harmony Biosciences reports topline results from a Phase 3 registrational clinical trial of ZYN002 in Fragile X syndrome did not meet the primary endp...
FDA posts a draft guidance outlining methods drugmakers should use to collect long-term safety and efficacy data once cell and gene therapy products a...
FDA warns San Juan, Puerto Rico-based Cellebration LLC that it is violating the Federal Food, Drug, and Cosmetic Act and agency regulations by refusin...
Acadia Pharmaceuticals says it will cease developing intranasal carbetocin after its Phase 3 COMPASS PWS trial of the drug for treating hyperphagia in...
FDA publishes a draft guidance with recommendations for expedited development and review of regenerative medicine therapies for serious conditions.
