FDA recommends that Agenus not submit its BOT/BAL colorectal cancer treatment for accelerated approval.
FDA classifies as official action indicated an April inspection of Zydus Lifesciences injectables manufacturing facility at Jarod, Gujarat, India.
Aveo Oncology says its Phase 3 trial of Fotivda plus BMS Opdivo in some renal cell cancer patients did not meet the progression-free survival primary ...
FDA clears a Globus Medical 510(k) for its ExcelsiusFlex with total knee arthroplasty option.
FDA grants Restore Medical a breakthrough device designation for its ContraBand device and its use in treating certain heart failures with reduced eje...
FDA approves a Phathom Pharmaceuticals NDA for Voquezna (vonoprazan) 10 mg tablets for relieving heartburn associated with non-erosive gastroesophagea...
FDA says two additional Warning Letters have been issued to Chinese medical device firms as part of its evaluation of defective plastic enteral syring...
FDA publishes a guidance with recommendations on clinical pharmacology considerations for conducting human radiolabeled mass balance studies of invest...
