FDA approves a Medtronic PMA for the PulseSelect Pulsed Field Ablation System for treating both paroxysmal and persistent atrial fibrillation.
Federal Register notice: FDA issues an order debarring Adam Michael Nagy for a period of 15 years from importing any drug into the U.S.
A Bloomberg Law article says FDA is doing little to address potentially violative social media drug ads.
The Massachusetts federal court approves a consent decree of permanent injunction against Pharmasol and its president for continuing to distribute adu...
FDA places a clinical hold on three CARsgen Therapeutics clinical trials due to chemistry, manufacturing and controls questions raised in a recent ins...
Four stakeholders submit specific technical concerns about an FDA draft guidance on topical ophthalmic drug quality considerations.
FDA approves a U.S. WorldMeds NDA for eflornithine for reducing the risk of relapse in certain adult and pediatric patients with high-risk neuroblasto...
Sens. Durbin and Blumenthal ask the Government Accountability Office to update its 2011 report on FDA oversight of medical device recalls, given a sex...
