Apnimed announces positive topline results from its second pivotal Phase 3 trial of AD109 (aroxybutynin and atomoxetine), a once-daily oral pill for t...
Gizmodo reports that FDA employees who have used Elsa told CNN the AI tool makes up reports and hallucinates confidently.
Baxter Healthcare recalls (Class 1) a mobile lift component used in several patient lift devices due to the risk of improper attachment.
Responding to congressional Democrats, the Congressional Budget Office says a nine-month increase in FDA drug review times would lead to fewer drugs b...
FDA issues an early alert highlighting serious safety concerns with Baxter's Novum IQ large volume infusion pump.
FDA researchers analyze the results of good clinical practice inspections from 2017 to 2023, finding that less than 1% resulted in an official action ...
FDA warns Grand Ledge, MI-based O3UV about multiple CGMP violations in its illegal production of autohemotherapy devices.
FDA warns Indias Glenmark Pharmaceuticals about CGMP violations in the production of finished drugs at one of its manufacturing facilities.
