FDA classifies a December inspection at Sun Pharmaceutical Industries Dadra, India facility as official action indicated.
FDAs Oncologic Drugs Advisory Committee unanimously votes (12 to 0) that the totality of data are adequate to support the use of minimal residual dise...
Enlivex Therapeutics reports mixed results from its Phase 2 study of Allocetra in patients with sepsis.
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...
