Several media outlets report that President Trump has signed off on a plan to remove FDA commissioner Marty Makary from his post.
FDA releases a new guidance outlining how drugmakers should design and conduct postapproval studies evaluating the safety of drugs and biologics used during pregnancy.
Several media outlets report that President Trump has signed off on a plan to remove FDA commissioner Marty Makary from his post.
FDA releases a new guidance outlining how drugmakers should design and conduct postapproval studies evaluating the safety of drugs and biologics used during pregnancy.
FDA approves a Partner Therapeutics BLA for Bizengri (zenocutuzumab-zbco) for adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion whose disease has progressed following prior systemic therapy. The monoclonal antibody is designed to target the extremely rare and aggressive form of bile duct cancer driven by NRG1 gene fusions.
FDA posts new technical guidance document outlining how sponsors should submit continuous glucose monitoring data collected during clinical trials for drugs and biologics.
