The CDER Office of Prescription Drug Promotion warns Alkermes about a misleading Vivitrol print ad that omits important risk information.
FDA accepts for review a Novartis supplemental BLA for Xolair (omalizumab) for treating nasal polyps in adult patients who do not respond well to intr...
The Senate votes 91-2 to approve legislation to reform the over-the-counter drug regulatory system.
FDAs Cardiovascular and Renal Drug Advisory Committee votes 11-2 against recommending approval of Correvio Pharmas vernakalant for use to rapidly conv...
FDA clears an ImpediMed 510(k) for Sozo, intended for use as an aid in assessing protein calorie malnutrition.
Attorney Michelle Yeary says a DC federal court decision might open the way for FDA Warning Letters to be considered final agency action.
The Council for Responsible Nutrition praises the Supreme Courts refusal to hear an Amrin appeal of a fish oil dietary supplement case.
FDA says 25 unapproved drug, dietary supplement and medical device product lines distributed by Basic Reset and Biogenyx, have been recalled.