FDA clears an Auris Health (Ethicon subsidiary) 510(k) for its Monarch surgery platforms expansion to endourological procedures.
Federal Register notice: FDA withdraws the accelerated approval of Acrotech Biopharmas NDA for Marqibo (vincristine sulfate liposome injection), indic...
FDA issues a complete response letter to Shanghai Junshi Biosciences and Coherus BioSciences on their BLA for toripalimab in combination with gemcitab...
FDA posts a final guidance entitled Electronic Submission of IND Safety Reports Technical Conformance Guide.
CDRH announces organizational changes that include new offices established within the Office of Product Evaluation and Quality.
FDA places a clinical hold on a Vertex Pharmaceuticals Phase 1/2 clinical trial of VX-880, an investigational stem cell-derived, fully differentiated ...
After 13 years at the agency, CDRH Digital Health Center of Excellence director Bakul Patel announces he will be leaving the agency early this month t...
FDA Review posts the Federal Register notices for the week ending 4/29/2022.