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FDA issues AbbVie a complete response letter for its BLA for trenibotulinumtoxinE, an investigational, fast-acting botulinum toxin...[ Price : $8.95]
FDA sends an untitled letter to Incyte Corp., warning that portions of the companys consumer-facing Web site for Niktimvo (axatili...[ Price : $8.95]
CDER's Office of Compliance releases a new annual report showing that it expanded enforcement and oversight activities in 2025.[ Price : $8.95]
FDA raises multiple manufacturing and quality control concerns at a Swiss drug substance facility operated by Lonza Group, followi...[ Price : $8.95]
FDA issues an early alert warning healthcare providers about a potentially dangerous defect in certain angiographic syringes inclu...[ Price : $8.95]
FDA and CMS unveil a new joint initiative aimed at significantly shortening the time it takes for innovative medical devices to re...[ Price : $8.95]
FDA sends Grace Therapeutics a complete response letter rejecting approval for its experimental treatment GTx-104 (nimodipine), ci...[ Price : $8.95]
A Clinical Trial Vanguard column demonstrates how synthetic biology is outstripping FDAs regulatory framework under the Supreme Co...