FDA reportedly is requiring additional safety data from Sarepta Therapeutics before the agency considers supporting use of the companys Duchenne muscu...
HHS secretary Robert F. Kennedy, Jr. approves a new federal directive removing thimerosal, a mercury-based preservative, from all influenza vaccines d...
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.
