FDA gives conditional approval to Pegasus Laboratories KBroVet-CA1 to treat idiopathic epilepsy in dogs.
FDA clears a Hyperfine Research 510(k) for its deep-learning image analysis software to measure brain structure and pathology in images acquired by th...
Three FDA staffers give an update on the agencys position on paclitaxel-coated devices used to treat peripheral arterial disease.
FDA issues an immediately effective guidance to help sponsors develop monoclonal antibodies and other therapeutic proteins for treating Covid-19.
FDA issues a report summarizing its Pandemic Recovery and Preparedness Plan Initiative work in the second half of 2020.
FDA releases minutes and meeting summaries for five PDUFA 7 negotiation meetings at the end of 2020.
Former CDER director Janet Woodcocks recent move to the Office of Commissioner sets in motion her likely elevation to acting commissioner after the pr...
Federal Register notice: HHS issues a final rule to promote transparency and fairness in civil enforcement actions.