An FDA advisory committee unanimously votes to recommend that Covid-19 vaccine makers formulate their upcoming fall shots to provide protection agains...
Amgen announces positive data from its Phase 3 clinical trial (MITIGATE) evaluating the efficacy and safety of Uplizna (inebilizumab-cdon) for treatin...
The Biosimilars Council calls on FDA to eliminate unnecessary clinical efficacy studies as part of streamlining the biosimilar development paradigm.
FDA publishes a draft guidance on processes and practices for Bioresearch Monitoring inspections.
A January FDA inspection at Jiangsu Hengrui Pharmaceuticals in Jiangsu, China, leads to an eight-observation Form FDA-483 that cites significant GMP d...
Federal Register notice: FDA withdraws 23 NDAs from multiple applicants after being notified by the application holders that the products were no long...
Federal Register notice: FDA seeks comments on an information collection extension entitled Medical Device Recall Authority 21 CFR Part 810.
FDA commissioner Robert Califf and two colleagues make the case for so-called pragmatic clinical research using real-world evidence.
