According to Reuters, FDA says it is doing a thorough review of 265 reports of suicidal thoughts or behavior that may be associated with taking Novo N...
FDA publishes a guidance on technical considerations for medical devices that use physiologic closed-loop control technology with recommendations for ...
FDA publishes a draft guidance to assist sponsors in developing various types of products to prevent or treat graft-versus-host disease.
FDA approves a Fabre-Kramer Pharmaceuticals NDA for Exxua (gepirone hydrochloride extended-release tablets) for treating major depressive disorder in ...
FDA approves a new indication for Pfizers Bosulif to treat some pediatric patients with chronic myelogenous leukemia.
CBS News says FDA has approved a labeling change for Novo Nordisks Ozempic to acknowledge reports of ileus following use of the drug.
Gilead says it ended the ENHANCE-2 trial of magrolimab in acute myeloid leukemia with TP53 mutations after determining it would not provide a benefit ...
Sens. Mullins and Booker introduce bipartisan legislation to permit electronic transmission of drug prescribing information to healthcare professional...
