Regeneron Pharmaceuticals stops a Phase 1/2a clinical trial of experimental anti-CD3 monoclonal antibody REGN7041 in patients with noninfectious uveit...
Sens. Ron Johnson (R-WI) and Rand Paul (R-KY) release a 2021 email from then-acting FDA commissioner Janet Woodcock in which she raised concerns about...
FDA plans a 9/9 meeting with the Reagan-Udall Foundation for the agency to hear public comments on perspectives involving opioid medication use.
Baxter is recalling (Class 1) certain lots of its Duo-Vent solution sets because the devices may allow air bubbles to enter the administration set dur...
FDA approves Lantheus Holdings Tauklarify (florquinitau F 18 injection) as a PET imaging agent to identify tau neurofibrillary tangle pathology in adu...
FDA grants OS Therapies a Type C statistical methods meeting with CBER to discuss 2.5-year overall survival data for OST-HER2, the companys investigat...
An FDA approval document shows that the accelerated approval of Replimunes Tudriqev came despite significant concerns about the reliability of efficac...
FDA has issued a warning letter to a Telangana, India, sterile drug manufacturing facility operated by Aurobindo Pharma subsidiary Eugia Pharma Specia...
