Former FDA commissioner Rob Califf tells a cardiology technology convention that the U.S. needs to make significant changes to improve population heal...
The Senate HELP Committee advances legislation sponsored by Sen. Rand Paul that he says will speed approval of biosimilar drugs by eliminating require...
A just-posted Form FDA 483 cites SGS France Life Sciences following an 8/2025 inspection, identifying multiple deficiencies involving bioanalytical me...
Johnson & Johnson reports promising topline results from the three-arm investigational Phase 3 MonumenTAL-6 study evaluating Tecvayli (teclistamab-cqy...
FDA investigators cite contract research organization Cliantha Research over data integrity, documentation and clinical research deficiencies followin...
A citizen petition urges FDA to establish a regulatory framework for implantable brain-computer interfaces designed to expand human sensory perception...
An analysis by PharmaVoice says FDA could remain without a Senate-confirmed commissioner for months as political and procedural hurdles complicate eff...
FDA acting commissioner Kyle Diamantas uses a Fox News editorial to tout agency steps he says are providing new jobs for American workers and protecti...
