Some dietary supplement manufacturers are concerned that FDA may be cracking down on products that include N-acetylcysteine, which is excluded from th...
FDA warns Predictive Biotech that it is marketing an unapproved and misbranded umbilical cord-derived product as a Covid-19 treatment.
Federal Register notice: FDA clarifies that an executive summary of a public meeting on Testing Methods for Asbestos in Talc and Cosmetic Products Con...
FDA holds up an emergency use authorization for using blood plasma therapy for treating Covid-19 patients until more data is presented to demonstrate ...
FDA issues a complete response letter to Gilead for its filgotinib to treat rheumatoid arthritis, seeking information from two studies.
FDA issues a complete response letter for a Phase 3 trial of BioMarins gene therapy for severe hemophilia A.
FDA issues an immediately effective guidance to answer questions about some regulatory and policy issues during the Covid-19 public health emergency.