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Otsuka reports positive topline interim data from an ongoing Phase 3 clinical trial of sibeprenlimab and its use for treating immu...[ Price : $8.95]
FDA sends Camurus a complete response letter on its NDA for CAM2029 (octreotide) extended-release injection and its use in treatin...[ Price : $8.95]
Federal Register notice: FDA extends the comment period for a 9/20 notice on a draft guidance entitled Chemical Analysis for Bioco...[ Price : $8.95]
FDA publishes a draft guidance with recommendations for the placement and content of drug interaction information in labeling for ...[ Price : $8.95]
Sangamo Therapeutics reaches an agreement with FDA on a clear regulatory pathway to accelerated approval for the companys gene the...[ Price : $8.95]
FDA names CDRH deputy director Michelle Tarver as the new Center director, replacing retiring head Jeff Shuren, who hand-picked hi...[ Price : $8.95]
FDA says a new open-access dataset on gait patterns in patients with Parkinsons disease may lead to novel medical devices.[ Price : $8.95]
Three stakeholders tell FDA they oppose the idea of the agency developing product-specific guidances to promote biosimilar develop...