FDA says it has worked with EPA and USDA to develop a biotechnology regulatory reform program as required by a presidential Executive Order.
FDA grants in part and denies in part a 14-year-old Kaiser Permanente petition on the development, implementation, and evaluation of REMS.
FDA grants China-based Mabwell an orphan drug designation for its novel Nectin-4-targeting antibody-drug conjugate 9MW2821 for treating esophageal can...
Tandem Diabetes Care recalls its t:connect mobile app (version 2.7) on the Apple iOS platform that is used with the companys t:slim X2 insulin pump.
Federal Register notice: FDA announces a 6/4 Psychopharmacologic Drugs Advisory Committee meeting to discuss a Lykos Therapeutics NDA for midomafetami...
CBER director Peter Marks says FDA is working to achieve 90% correct decisions on gene therapy accelerated approvals.
Three Winston & Strawn attorneys say that by declining to hear an appeal, the Supreme Court has affirmed that some state law claims may be preempted b...
FDA warns Chinas Bioptimal International about multiple violations at a Singapore facility manufacturing two unapproved catheters.
