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...
FDA releases a form FDA-483 with six observations from an inspection at Indias Global Calcium active pharmaceutical ingredient manufacturing facility....
Consumers for Dental Choice and two other advocacy groups again petition FDA to ban the use of mercury amalgams in dentistry, especially for vulnerabl...
