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.
FDA warns Chandler, AZ-based Adept Life Science about CGMP and misbranding violations in its production of dietary supplements.
FDA issues the FY 2022 GDUFA Science and Research Report with information on projects in 13 scientific areas.
Two FDAers introduce a journal issue exploring ways in which clinical pharmacology innovations can expand the development and approval of biosimilars.
FDA publishes a draft guidance with considerations for designing and conducting externally controlled trials for drug and biological products.
