FDA warns Clearfield, UT-based Yusef Manufacturing Laboratories about multiple repeated CGMP violations in its production of finished drugs.
Veru Inc. announces positive efficacy and safety results from an interim analysis of a Phase 3 Covid-19 clinical trial evaluating oral sabizabulin 9 m...
FDA publishes two guidances giving submitters using the 510(k) Safety and Performance Based Pathway for two specific products an option to use perform...
Attorney Jeffrey Shapiro says companies should be careful when calculating for FDA the risk of a medical device malfunction.
A CDRH official says a new draft cybersecurity guidance has teeth that make it more likely that companies that follow its recommendations will achieve...
Federal Register notice: FDA announces that it is withdrawing approval of a Secura Bio indication for Copiktra (duvelisib) for treating relapsed or re...
FDA places a clinical hold on an Ocugen Phase 2/3 immuno-bridging and broadening study for its Covid-19 vaccine Covaxin (BBV152) after the World Healt...
FDAs Bioresearch Monitoring Program metrics report for fiscal year (FY) 2021 shows substantially fewer clinical investigator and IRB inspections condu...