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...
FDA warns Auckland, New Zealand-based Adept Medical about Quality System and other violations in its production of ventilation tubes.
FDA warns Milan, Italy-based Eurosirel about CGMP violations in its production of finished drugs.
FDA publishes a draft guidance with recommendations to oncologic drug sponsors about measuring ovarian toxicity in relevant clinical trials.
