FDA convenes a 2/13 advisory committee meeting to discuss the clinical significance of Abbott Medicals TRILUMINATE pivotal trial that evaluated the co...
FDA clears a Proscia 510(k) for its Concentriq AP-Dx, a diagnostic software for pathologists for viewing, interpreting, and managing whole slide image...
FDA removes a clinical hold against Hemogenyx Pharmaceuticals IND for the companys chimeric antigen receptor T-cells therapy for treating acute myeloi...
FDA approves a Takeda NDA for Eohilia (budesonide oral suspension), indicated for treating eosinophilic esophagitis.
FDA grants Disc Medicine an orphan drug designation for DISC-3405 for treating patients with polycythemia vera.
FDA grants Samsung Electronics a de novo authorization for a sleep apnea feature using a compatible Samsung Galaxy Watch and phone.
FDA clears a Fresenius Medical Care 510(k) for its 5008X Hemodialysis High-Volume System.
FDA issues a final rule to amend its regulations about the use of master files for biological products.
