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Federal Register Notice: FDA announces a 12/6 meeting of its Bone, Reproductive and Urologic Drugs Advisory Committee that will di...[ Price : $8.95]
Federal Register Notice: FDA detemines the regulatory review period for Eisais NDA for Fycompa (perampanel) that applies to a pate...[ Price : $8.95]
Federal Register Notice: FDA determines the regulatory review period for an Amylin Pharmaceuticals NDA for Myalept (metreleptin fo...[ Price : $8.95]
Federal Register Notice: FDA determines the regulatory review period for an Eisai NDA for Belviq that applies to a patent extensio...[ Price : $8.95]
FDA approves Amgens Amjevita, a biosimilar copy of Abbotts Humira (adalimumab) for multiple inflammatory diseases.[ Price : $8.95]
Teva Pharmaceutical Industries plans an NDA for the end of the year after reporting statistically significant results in a second ...[ Price : $8.95]
Journalism professor Charles Seife faults FDA and reporters for a situation in which journalists are willing to trade early access...[ Price : $8.95]
The Medical Information Working Group asks a Massachusetts federal court to look at FDA enforcement against off-label promotion in...