Intellia Therapeutics starts a rolling BLA submission for its experimental gene-editing therapy lonvoguran ziclumeran, or lonvo-z, as a one-time treat...
FDA identifies significant deficiencies at BayCare Integrated Service Center, an outsourcing facility in Temple Terrace, FL, following a March inspect...
FDA accepts for priority review a Jazz Pharmaceuticals supplemental BLA for Ziihera (zanidatamab-hrii) for use in combination regimens for first-line ...
A federal judge dismisses a lawsuit brought by homeopathy advocates and a product distributor challenging FDAs decision to tighten oversight of homeop...
Concerns that political pressure could undermine the U.S. drug approval system intensify this week after a new White House directive on psychedelic th...
FDA plans to unveil a significant shift in how clinical trials are conducted and regulated, announcing major steps to implement real-time clinical tri...
Galaxy Therapeutics has submitted the final module of a PMA for its SEAL device, a treatment designed for patients with wide-neck bifurcation brain an...
CDER's Office of Compliance releases a new annual report showing that it expanded enforcement and oversight activities in 2025.
