FDA releases the proposed recommendations for the eighth reauthorization of the Prescription Drug User Fee Act, outlining changes to drug review, manu...
Foundation for Prader-Willi Research warns that real-world reports of edema and other serious heart and respiratory problems among patients taking Neu...
The Department of Justice seeks an injunction to stop Steiner Biotechnology from manufacturing and marketing adulterated and misbranded dental medical...
FDA is raising questions about the risk/benefit of ADC Therapeutics Zynlonta as a second-line treatment for diffuse large B-cell lymphoma.
FDA issues a draft guidance proposing a risk-based framework for evaluating the container-closure systems used to package human drugs and biologics.
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...
