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A developer of drugs to treat neovascular age-related macular degeneration raises issues with an FDA draft guidance on developing ...[ Price : $8.95]
FDA accepts for priority review an Iovance Biotherapeutics BLA submission for lifileucel, a tumor infiltrating lymphocyte therapy ...[ Price : $8.95]
Janssen submits an NDA to FDA for an investigational combination of Opsumit and Cialis to treat some adults with pulmonary arteria...[ Price : $8.95]
FDA clears a Think Surgical 510(k) for its TMINI Miniature Robotic System for performing total knee replacement surgeries.[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Non-Clinical Performance Assessment of Tissue Containment S...[ Price : $8.95]
Pfizer says its hemophilia drug marstacimab met the primary endpoints in the Phase 3 BASIS trial.[ Price : $8.95]
CDERs Office of New Drugs denies an Akebia Therapeutics dispute resolution request following receipt of a 3/22 complete response l...[ Price : $8.95]
Two stakeholders make recommendations for improving an FDA draft guidance on clinical trial considerations to support accelerated ...