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.
FDA raises multiple manufacturing and quality control concerns at a Swiss drug substance facility operated by Lonza Group, following an inspection in ...
FDA announces several actions aimed at accelerating the development of treatments for serious mental illness, following a recent executive order from ...
A recent FDA Warning Letter signals a broader regulatory focus on how drugmakers use artificial intelligence, according to a new analysis by law firm ...
FDA issues AbbVie a complete response letter for its BLA for trenibotulinumtoxinE, an investigational, fast-acting botulinum toxin intended for aesthe...
FDA sends an untitled letter to Incyte Corp., warning that portions of the companys consumer-facing Web site for Niktimvo (axatilimab-csfr) contain fa...
