Federal Register notice: FDA makes available a draft guidance entitled Facility Readiness: Goal Date Decisions Under GDUFA.
FDA sends Supernus Pharmaceuticals a complete response letter on its NDA for SPN-830 (apomorphine) infusion device for the continuous treatment of mot...
Merck reports positive top-line results from a pivotal Phase 3 trial (STELLAR) evaluating the safety and efficacy of sotatercept, an investigational d...
Federal Register notice: FDA announces the fee rate for using a priority review voucher for fiscal year 2023.
Federal Register notice: FDA makes available final guidances on postmarket surveillance and post-approval study orders.
FDA approves scPharmaceuticals Furoscix (furosemide injection) for treating congestion due to fluid overload in adults with New York Heart Association...
Zeiss Medical Technology gains 510(k) clearance for MTLawton, disposable bipolar forceps made from a copper-base alloy.
FDA clears a Copan Diagnostics 510(k) for its Colibr, a semi-automated pre-analytical processor that is part of the companys WASPLab laboratory automa...
