Valneva says it has voluntarily withdrawn its BLA for Ixchiq, the companys chikungunya vaccine, based on FDA safety-related restrictions on the produc...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...
Moderna and Merck report updated five-year follow-up data that show their personalized mRNA cancer vaccine candidate, intismeran autogene, significant...
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FDA posts a draft guidance outlining how drug developers can use minimal residual disease and complete response as primary endpoints in multiple myelo...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 alerts healthcare providers to a potentially high-risk issue involving dialysis tubing sets used with Prismaflex systems after manufacturer Vantiv...
FDA lifts a clinical hold against GH Researchs investigational antidepressant GH001, clearing the way for patient enrollment in the U.S. and advancing...
FDA inspectors cite Oklahoma-based outsourcing facility Qualgen for a wide range of manufacturing and quality control failures during a recent inspect...
