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Two stakeholders make recommendations for improving an FDA draft guidance on clinical trial considerations to support accelerated approval of oncology...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...
Federal Register notice: FDA releases a draft guidance entitled Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic D...
