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Regeneron Pharmaceuticals and Sanofi say they will seek FDA approval next year for Dupixent (dupilumab) and its use in treating ch...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Facility Readiness: Goal Date Decisions Under GDUFA.[ Price : $8.95]
FDA sends Supernus Pharmaceuticals a complete response letter on its NDA for SPN-830 (apomorphine) infusion device for the continu...[ Price : $8.95]
Merck reports positive top-line results from a pivotal Phase 3 trial (STELLAR) evaluating the safety and efficacy of sotatercept, ...[ Price : $8.95]
Federal Register notice: FDA announces the fee rate for using a priority review voucher for fiscal year 2023.[ Price : $8.95]
Federal Register notice: FDA makes available final guidances on postmarket surveillance and post-approval study orders.[ Price : $8.95]
FDA approves scPharmaceuticals Furoscix (furosemide injection) for treating congestion due to fluid overload in adults with New Yo...[ Price : $8.95]
Zeiss Medical Technology gains 510(k) clearance for MTLawton, disposable bipolar forceps made from a copper-base alloy.