FDA publishes a draft guidance to assist sponsors in developing various types of products to prevent or treat graft-versus-host disease.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...
FDA approves a Viatris and Ocuphire Pharma NDA for Ryzumvi (phentolamine ophthalmic solution) 0.75% for treating pharmacologically-induced mydriasis (...
FDA clears a Boston Scientific 510(k) for its AVVIGO+ Multi-Modality Guidance System, which the company describes as a streamlined platform that enhan...
