CDER releases its proposed 2023 guidance agenda showing 98 planned new and revised guidances in 18 categories.
FDA publishes a draft guidance with recommendations about developing drugs for treating early Lyme disease as manifested by erythema migrans.
FDA says IBSA Pharma is recalling 27 lots of Tirosint-Sol oral solution due to subpotency.
Federal Register notice: FDA announces a 4/4-5 advisory committee meeting of the Science Advisory Board to the National Center for Toxicological Resea...
Pfizer says it gained an expanded indication in late December for Ibrance (palbociclib) to include its use in combination with an aromatase inhibitor ...
FDA clears a Clarius Mobile Health 510(k) for its new MSK (musculoskeletal) AI model, which automatically identifies and measures tendons in the foot,...
Xenex Disinfection Services files a de novo petition for its LightStrike+ ultraviolet room disinfection technology.
FDA warns Bethesda, MD-based RightEye that it is promoting off-label use of its adulterated and misbranded RightEye Vision System.
