FDA says that beginning 6/12 it will expand in-person industry meetings to include requests for Type B End-of-Phase 2 requests at CDER/CBER.
CDRH announces a 9/6 Patient Engagement Advisory Committee meeting to discuss and make recommendations on Advancing Health Equity in Medical Devices....
Sanofi says data from a Phase 2 trial of frexalimab significantly reduced disease activity in patients with relapsing multiple sclerosis.
FDA alerts patients and healthcare providers to concerns about compounded semaglutide that is being produced as an alternative to approved versions Oz...
The CDER Office of Surveillance and Epidemiology 2022 annual report highlights activities in public health emergencies, drug risk assessment, and drug...
Oncology Center of Excellence director Richard Pazdur explains what FDA can and cant do to address cancer drug shortages.
Federal Register notice: FDA intends to inactivate the registration of establishments that manufacture human cells, tissues, or cellular or tissue-bas...
FDA accepts for priority review an Iovance Biotherapeutics BLA submission for lifileucel, a tumor infiltrating lymphocyte therapy for treating patient...
