FDA warns Orange, CA-based neurologist Namita Goyal about violations found in a bioresearch monitoring inspection of a clinical trial she conducted.
FDA warns Phoenix, AZ-based Amnio Technology it is illegally manufacturing and distributing amniotic membrane and fluid products that have significant...
Otsuka reports positive topline interim data from an ongoing Phase 3 clinical trial of sibeprenlimab and its use for treating immunoglobulin A nephrop...
FDA sends Camurus a complete response letter on its NDA for CAM2029 (octreotide) extended-release injection and its use in treating patients with acro...
Federal Register notice: FDA extends the comment period for a 9/20 notice on a draft guidance entitled Chemical Analysis for Biocompatibility Assessme...
FDA publishes a draft guidance with recommendations for the placement and content of drug interaction information in labeling for human drugs and biol...
Sangamo Therapeutics reaches an agreement with FDA on a clear regulatory pathway to accelerated approval for the companys gene therapy candidate ST-92...
FDA names CDRH deputy director Michelle Tarver as the new Center director, replacing retiring head Jeff Shuren, who hand-picked his replacement.
