A new report from the Association for Accessible Medicines calls for changes to FDA policies, patent law, pharmacy benefit manager practices and feder...
FDA grants Pharming Group expanded approval for Joenja (leniolisib) tablets for treating activated phosphoinositide 3-kinase delta syndrome in childre...
FDA extends by three months its review of an Exelixis NDA for zanzalintinib, in combination with atezolizumab, for treating patients with metastatic c...
Oncology Center of Excellence director Angelo de Claro says the center will build on initiatives established under longtime and former OCE chief Richa...
FDA grants a priority review for a Roche sBLA for Espryng to treat myelin oligodendrocyte glycoprotein antibody-associated disease, an autoimmune dise...
BMC Medical recalls its Luna G3 APAP (Model LG3600), an auto-adjusting positive airway pressure machine for treating obstructive sleep apnea, due to a...
FDA issues a partial clinical hold on Biohavens opakalim (BHV-7000) due to nonclinical characterization of certain metabolites documented in rodent te...
FDA releases the Form FDA-483 with three observations from an inspection at New Albany, OH-based XeCare.
