FDA approves an Eisai/Biogen supplemental BLA for Leqembi (lecanemab-irmb) and its intravenous use once every four weeks as maintenance dosing in Alzh...
Pfizer agrees to pay $59.7 million to resolve allegations that its subsidiary, Biohaven Pharmaceutical, engaged in previous illegal kickback schemes.
Vanda Pharmaceuticals files an NDA for tradipitant for treating motion sickness.
FDA clears a ClearPoint Neuro 510(k) for its ClearPoint Navigation Software Version 3.0, which the company says introduces an intraoperative computed ...
FDA grants Clarity Pharmaceuticals a fast track designation for 64Cu-SAR-bisPSMA for positron emission tomography imaging prostate cancer lesions in p...
Caranx Medical files a PMA for its TAVIpilot AI Software for real-time intra-operative guidance of transcatheter heart valve implantation.
ALX Oncology plans to discuss with FDA its path for seeking accelerated approval for CD47-blocker evorpacept based on positive updated data from the A...
FDA approves a Medexus NDA for Grafapex (treosulfan) for use with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transpl...
