FDA says it is working with additional manufacturers of hemodialysis and peritoneal dialysis systems to determine the potential risk of patient exposu...
FDA grants Neuromod Devices a de novo request to market Lenire, the first bimodal neuromodulation device for treating tinnitus.
Aclaris Therapeutics says a Phase 2 clinical study investigating the efficacy and safety of zunsemetinib in treating hidradenitis suppurativa did not ...
The Association for Accessible Medicines urges FDA to continue to revise a draft guidance on pre-submission facility correspondence.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 ...
