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FDA publishes a guidance with recommendations on clinical pharmacology considerations for conducting human radiolabeled mass balan...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Blood Pressure and Pulse Donor Eligibility Requirements: Co...[ Price : $8.95]
FDA recommends that Agenus not submit its BOT/BAL colorectal cancer treatment for accelerated approval.[ Price : $8.95]
FDA classifies as official action indicated an April inspection of Zydus Lifesciences injectables manufacturing facility at Jarod,...[ Price : $8.95]
Aveo Oncology says its Phase 3 trial of Fotivda plus BMS Opdivo in some renal cell cancer patients did not meet the progression-fr...[ Price : $8.95]
FDA clears a Globus Medical 510(k) for its ExcelsiusFlex with total knee arthroplasty option.[ Price : $8.95]
FDA grants Restore Medical a breakthrough device designation for its ContraBand device and its use in treating certain heart failu...[ Price : $8.95]
FDA approves a Phathom Pharmaceuticals NDA for Voquezna (vonoprazan) 10 mg tablets for relieving heartburn associated with non-ero...