Iovance Biotherapeutics files a rolling BLA submission for lifileucel, a tumor infiltrating lymphocyte therapy for treating certain patients with adva...
FDA issues two final guidances on transition plans for Covid-19-related medical devices that were granted emergency use authorizations or were allowed...
Pushing randomized clinical trials, FDA issues a draft guidance entitled Clinical Trial Considerations to Support Accelerated Approval of Oncology The...
CBER's Office of Therapeutic Products plans a 4/27 public listening meeting to obtain feedback on methods and approaches for capturing post-approval s...
CDER's Office of Prescription Drug Promotion (OPDP) says it is monitoring very closely the increasing use of social media platforms that promote presc...
CDRH launches a new Web page to discuss mission-critical priorities of data and technology innovations and provide information and resources on its Di...
FDA approves a Getinge PMA for its iCast covered stent system for treating patients with iliac arterial occlusive disease.
Pharmaceutical Research and Manufacturers of America says a recent FDA draft guidance on oncologic drug development provides limited information on ho...
