Former FDA Oncology Center for Excellence director Richard Pazdur warns that political interference and internal upheaval are eroding the agency’s ability to function as a science-driven organization.
FDA issues an untitled letter to BeOne Medicines USA, finding that its direct-to-consumer television advertisement for cancer drug Brukinsa (zanubrutinib) misbrands the drug.
Former FDA Oncology Center for Excellence director Richard Pazdur warns that political interference and internal upheaval are eroding the agency’s ability to function as a science-driven organization.
FDA issues an untitled letter to BeOne Medicines USA, finding that its direct-to-consumer television advertisement for cancer drug Brukinsa (zanubrutinib) misbrands the drug.
FDA says Novo Nordisk and Lilly should remove statements about the potential for suicidal ideation and behavior from labeling for their weight loss drugs Saxenda, Wegovy, and Zepbound, following an agency comprehensive evaluation that found no association.
The National Security Commission on Emerging Biotechnology recommends 22 policy actions in five key areas to modernize FDA medical biotechnology regulation.
