Pennsylvania attorney general Dave Sunday says 49 states are sharing a $202 million settlement with Gilead Sciences to resolve charges that the compan...
Two stakeholders urge FDA to use the PDUFA 8 reauthorization to emphasize the need for congressional funding and take steps to improve transparency an...
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...
