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...
Capricor Therapeutics plans to amend its BLA for deramiocel to modify its proposed indication after discussions with FDA produced a potential path tow...
FDA grants Bristol-Myers Squibb accelerated approval for Zenbexus (iberdomide) in combination with daratumumab and hyaluronidase-fihj and dexamethason...