FDA approves Incytes Niktimvo for some adult and pediatric host-versus-graft treatments.
FDA and the American Society of Clinical Oncology announce a 10/1 joint workshop entitled Measuring Toxicity in Reproductive Organs During Oncology Dr...
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 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.
FDA warns Jordans Nowrez and Ismail Shukri Company about CGMP violations in the production of OTC drugs.