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.
CDERs Office of New Drugs denies an Akebia Therapeutics dispute resolution request following receipt of a 3/22 complete response letter for vadadustat...
Two stakeholders make recommendations for improving an FDA draft guidance on clinical trial considerations to support accelerated approval of oncology...
FDA sends iRhythm Technologies a Warning Letter that cites violations from an 8/22 agency inspection of the companys Zio heart monitor manufacturing s...
