FDA solicits statements of interest in being one of no more than five drug and biologic developers to participate in the initial cohort for the Commis...
University researchers say they found relatively few instances in which Oncology Drugs Advisory Committee members reported difficulty in voting on a q...
CDER issues a white paper tracing the history of selective safety data collection (SSDC) and plans for the future.
FDA extends by three months its review of a GSK BLA for Blenrep (belantamab mafodotin) combinations for treating patients with relapsed or refractory ...
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...
