FDA accepts for priority review a Bristol Myers Squibb NDA for repotrectinib and its use for treating patients with ROS1-positive locally advanced or ...
FDA approves Blue Earth Diagnostics Posluma (flotufolastat F 18) injection, a prostate-specific membrane antigen-targeted positron emission tomography...
A developer of drugs to treat neovascular age-related macular degeneration raises issues with an FDA draft guidance on developing drugs for the condit...
FDA accepts for priority review an Iovance Biotherapeutics BLA submission for lifileucel, a tumor infiltrating lymphocyte therapy for treating patient...
Janssen submits an NDA to FDA for an investigational combination of Opsumit and Cialis to treat some adults with pulmonary arterial hypertension.
FDA clears a Think Surgical 510(k) for its TMINI Miniature Robotic System for performing total knee replacement surgeries.
Federal Register notice: FDA makes available a final guidance entitled Non-Clinical Performance Assessment of Tissue Containment Systems Used During P...
Pfizer says its hemophilia drug marstacimab met the primary endpoints in the Phase 3 BASIS trial.
