Federal Register notice: FDA makes available a draft guidance entitled Assessment of Ovarian Toxicity in Premenopausal Adults During Drug Development ...
Federal Register notice: FDA renews its Oncologic Drugs Advisory Committee for an additional two years.
FDA identifies eight broad areas for the GDUFA FY 2025 science and research priorities.
PTC Therapeutics says its utreloxastat failed to meet the primary endpoint in a Phase 2 ALS study and development will not continue.
FDA issues an alert about serious adverse event reports associated with Bluebird Bios Skysona (elivaldogene autotemcel), a gene therapy for treating b...
FDA extends by three months its review of a Soleno Therapeutics NDA for DCCR (diazoxide choline) extended-release tablets for treating Prader-Willi sy...
Federal Register notice: FDA makes available a final guidance entitled Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Chang...
FDA commissioner Robert Califf asks Congress to give the agency the authority to set standards for postmarket evaluation of artificial intelligence in...
