CDER Office of New Drug Policy director Maarika Kimbrell leaves the agency to re-enter private legal practice at Morgan Lewis as a partner resident.
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 places a clinical hold on a PepGen IND application for a Phase 1 trial of PGN-EDODM1 to treat myotonic dystrophy Type 1.
