FDA clears a Big Health 510(k) for its SleepioRx, a digital therapeutic intended for treating chronic insomnia/insomnia disorder as an adjunct to usua...
Federal Register notice: FDA seeks comments on the abuse potential, medical usefulness, trafficking, and impact of scheduling changes for eight drug s...
Federal Register notice: FDA announces a 10/7 Science Board Advisory Committee meeting that will hear an update from the new Alternative Methods Subco...
Two stakeholders call on FDA to make major changes to a draft guidance on the REMS logic model that is intended to link program design with assessment...
The drug development consulting firm Rahaa asks FDA to require stability studies under refrigerated conditions for generic versions of prednisolone op...
Federal Register notice: FDA renews for two years its Peripheral and Central Nervous System Drugs advisory committee.
FDA approves a Galderma BLA for Nemluvio (nemolizumab), a pre-filled pen for subcutaneous injection for adults with prurigo nodularis.
FDA warns Lublin, Poland, physician Konrad Rejdak about Bioresearch Monitoring violations in a clinical study for which he was the study director.
