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FDA identifies eight broad areas for the GDUFA FY 2025 science and research priorities.[ Price : $8.95]
PTC Therapeutics says its utreloxastat failed to meet the primary endpoint in a Phase 2 ALS study and development will not continu...[ Price : $8.95]
FDA issues an alert about serious adverse event reports associated with Bluebird Bios Skysona (elivaldogene autotemcel), a gene th...[ Price : $8.95]
FDA extends by three months its review of a Soleno Therapeutics NDA for DCCR (diazoxide choline) extended-release tablets for trea...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Transitional Enforcement Policy for Ethylene Oxide Steriliz...[ Price : $8.95]
FDA commissioner Robert Califf asks Congress to give the agency the authority to set standards for postmarket evaluation of artifi...[ Price : $8.95]
FDA warns Auckland, New Zealand-based Adept Medical about Quality System and other violations in its production of ventilation tub...[ Price : $8.95]
FDA warns Milan, Italy-based Eurosirel about CGMP violations in its production of finished drugs.