Federal Register notice: FDA issues a final rule to amend its regulations to address the use of master files by applications licensed under the Public...
FDA accepts for priority review a Lykos Therapeutics NDA for midomafetamine capsules used in combination with psychological intervention for treating ...
FDA makes available a draft guidance entitled FDA Advanced Manufacturing Technologies Designation Program.
Federal Register notice: FDA announces a 5/20-21 public workshop entitled FY 2024 Generic Drug Science and Research Initiatives Workshop.
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.
