FDA tells BeyondSpring Pharmaceuticals a second study is needed to demonstrate substantial benefit of its plinabulin in preventing chemotherapy-induce...
Federal Register notice: FDA classifies isocapnic ventilation devices into Class 2 (special controls), following a de novo classification request from...
Federal Register notice: FDA seeks comments on an information collection extension entitled Financial Disclosure by Clinical Investigators.
Federal Register notice: FDA renews its Patient Engagement Advisory Committee for an additional two years beyond the charter expiration date.
FDA approves Janssens Darzalex Faspro plus Kyprolis and dexamethasone to treat some multiple myelomas.
FDA publishes 15 GDUFA scientific and research priorities for FY 2022.
FDA extends by three months its review of a CTI BioPharma NDA for treating adult patients with intermediate or high-risk primary or secondary myelofib...
FDA lifts its clinical hold on Statera Biopharmas entolimod for treating acute radiation syndrome.