FDA clears a Medicrea Group 510(k) for its IB3D range of 3D-printed Titanium interbody devices with its AdapTEK in-house additive manufacturing platfo...
Janssen Biotech files a supplemental BLA for Darzalex (daratumumab) and its expanded use in combination with bortezomib, melphalan and prednisone for ...
FDA approves a RxSight adjustable intraocular lens for use following cataract surgery.
FDA releases its latest batch of Warning Letters that includes Hubei Danjiangkou Danao Pharmaceutical and Vita-Pure.
FDA commissioner Scott Gottlieb says the agency has issued a new guidance and taken other steps to help sponsors test and seek approval for generic ab...
Federal Register notice: FDA seeks comments on an information collection extension for 513(g) Request for Information OMB Control Number 0910-0705.
Cytokinetics suspends its tirasemtiv drug development program after receiving disappointing data from the VITALITY-ALS Phase 3 clinical trial in patie...
Federal Register notice: FDA determines that Takedas Trintellix (vortioxetine hydrobromide) oral tablet, indicated for treating major depressive disor...