Valneva says it has voluntarily withdrawn its BLA for Ixchiq, the companys chikungunya vaccine, based on FDA safety-related restrictions on the produc...
FDA accepts for priority review a Celcuity NDA for gedatolisib in patients with hormone receptorpositive, HER2-negative, PIK3CA wild-type advanced bre...
Novo Nordisk submits to FDA additional studies and analyses it says support its petition asking the agency to act against compounded forms of its sema...
FDA warns Temecula, CA-based Prodrome Sciences USA about violations in its conduct of a clinical trial without submitting an IND.
FDA posts a draft guidance outlining how drug developers can use minimal residual disease and complete response as primary endpoints in multiple myelo...
FDA lifts a clinical hold against GH Researchs investigational antidepressant GH001, clearing the way for patient enrollment in the U.S. and advancing...
FDA alerts healthcare providers to a potentially high-risk issue involving dialysis tubing sets used with Prismaflex systems after manufacturer Vantiv...
FDA inspectors cite Oklahoma-based outsourcing facility Qualgen for a wide range of manufacturing and quality control failures during a recent inspect...
