The Association for Accessible Medicines urges FDA to continue to revise a draft guidance on pre-submission facility correspondence.
FDA accepts for review a Regeneron Pharmaceuticals supplemental BLA for Dupixent (dupilumab) for treating adults and adolescents aged 12 years and old...
The National Cancer Institute raises concerns about an FDA guidance that requires studies of oncologic investigational agents to enroll additional pat...
An unfavorable interim analysis leads Incyte to discontinue the Phase 3 LIMBER-304 myelofibrosis trial due to efficacy concerns.
Federal Register notice: FDA announces a 4/20 Orthopedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee meeting to review ...
Federal Register notice: FDA provides notice that is has received a copy of a patent infringement complaint that had been filed against a pending bios...
FDA clears an Abbott 510(k) for its FreeStyle Libre 2 and FreeStyle Libre 3 integrated continuous glucose monitoring system sensors for integration wi...
CDER director Patrizia Cavazzoni says the agency is stepping up its actions to prevent contaminated drug products, including cough/cold syrups with di...
