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...
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...
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...
FDA releases the Form FDA-483 issued following an inspection at Indias Reliance Life Sciences drug manufacturing facility in Navi Mumbai.
