FDA accepts for review a Blueprint Medicines supplemental NDA for Ayvakit (avapritinib) for treating adults with indolent systemic mastocytosis.
FDA issues an immediately-in-effect guidance on compounding certain ibuprofen products that is intended to alleviated product shortages due to increas...
Federal Register notice: FDA classifies computerized behavioral therapy devices for treating symptoms of gastrointestinal conditions into Class 2 (spe...
Federal Register notice: FDA classifies intense pulsed light devices for managing dry eye into Class 2 (special controls).
A just-released FDA memo to commissioner Robert Califf and chief scientist Namandj Bumpus recommends that they order the withdrawal of Covis Pharmas M...
FDA accepts for review an Intercept Pharmaceuticals NDA resubmission for obeticholic acid for use in treating patients with pre-cirrhotic liver fibros...
Medtronic updates a 2022 recall of its HeartWare Ventricular Assist Device System batteries and is now requesting the return of 12 batteries for ongoi...
FDA plans a 4/19 Anesthetic and Analgesic Drug Products Advisory Committee meeting to discuss a postmarketing requirement issued to NDA application ho...
