FDA approves a Takeda NDA for Eohilia (budesonide oral suspension), indicated for treating eosinophilic esophagitis.
FDA makes available a draft guidance entitled Use of Data Monitoring Committees in Clinical Trials.
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 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.
