FDA grants PureTech Health a fast-track designation for LYT-200 in combination with anti-PD1 therapy for treating recurrent/metastatic head and neck s...
FDA grants 16 Bit Inc. a de novo marketing authorization for Rho, an AI-enabled software device aimed at improving osteoporosis screening.
As FDA continues to evaluate the risk of suicidal thoughts or actions in patients taking glucagon-like peptide-1 receptor agonists, the European Medic...
FDA approves new safety labeling for Veloxis Pharmaceuticals Envarsus XR (tacrolimus), indicated for use with other medicines to help prevent organ re...
FDAer Susan Rosencrance tells the agencys Generic Drug Forum that FDA has chosen nine applicants to participate in a Quality Maturity Management evalu...
Federal Register notice: FDA determines that UCBs Kemstro (baclofen) orally disintegrating tablets, 10 mg and 20 mg, were not withdrawn from sale for ...
Federal Register notice: FDA determines that Pfizers Vistaril (hydroxyzine pamoate) oral suspension, 25 mg/5 mL, was not withdrawn from sale for reaso...
Oncolytics Biotech asks FDA for a 2nd quarter Type C meeting to agree on the design and objectives for a registration-enabling trial of its pelareorep...
