Acadia Pharmaceuticals sells its Rare Pediatric Disease Priority Review Voucher for $150 million.
FDA approves an Envoy Medical IDE for its pivotal study of the Acclaim Fully Implanted Cochlear Implant.
FDA issues an untitled letter to Chinas Shandong Boyuan Pharmaceutical Co. about CGMP deviations in its manufacturing of active pharmaceutical ingredi...
FDA warns Grand Prairie, TX-based Analytical Food Laboratories about CGMP violations in its work as a drug contract testing laboratory.
FDA clears a SimBioSys 510(k) for TumorSight Viz to expand its use by breast surgeons through artificial intelligence-based image processing.
FDA extends by three months its priority review of a Merus BLA for Zeno (zenocutuzumab) for treating patients with certain types of lung and pancreati...
Four rare disease stakeholders say they support an FDA plan to create a Rare Disease Innovation Hub and suggest its initial priorities.
Attorney Bradley Thompson says he is surprised and disappointed that FDA is not approving enough new consensus standards to support digital health and...
