Four stakeholders provide additional information to the U.S. Patent and Trademark Office about its collaboration with FDA.
FDAers in CDER and the Oncology Center of Excellence discuss the use of minimal residual disease (MRD) data in hematologic clinical trials and treatme...
Servier says a Phase 3 clinical trial assessing glioma drug vorasidenib met its primary and secondary endpoints.
A former Becton Dickinson medical director petitions FDA to scrutinize the companys 2017 510(k) clearance for the GalaForm 3D due to label misreprese...
FDA announces a 5/2 Webcast entitled Navigating the First ICH Generic Drug Draft Guideline M13A Bioequivalence for Immediate-Release Solid Oral Dosag...
FDA places a clinical hold on Mersana Therapeutics Phase 1 trial of XMT-2056 after the company suspended it due to a recent patient death that was dee...
FDA posts a final guidance entitled Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and C...
FDA approves an Acadia Pharmaceuticals NDA for Daybue (trofinetide) oral solution for treating Rett syndrome.
