FDA lifts a clinical hold against Viking Therapeutics VK0214 in patients with X-linked adrenoleukodystrophy.
Merck halts a Phase 3 LYNK-003 trial investigating Lynparza (olaparib) with or without bevacizumab for treating patients with unresectable or metastat...
CDER director Patrizia Cavazzoni selects associate director for controlled substances Marta Sokolowska to serve as deputy Center director for substanc...
The Washington Legal Foundation says an OIG advisory opinion puts life sciences companies on notice to be cautious in the way they fund continuing edu...
California pain doctor Gerald Sacks agrees to pay $271,259.12 to resolve anti-kickback allegations involving drugs manufactured by Purdue Pharma and D...
FDA grants breakthrough device designation for the Roche Elecsys Amyloid Plasma Panel that detects and measures Alzheimers disease biomarkers in blood...
FDA accepts for priority review an Apellis Pharmaceuticals NDA for intravitreal pegcetacoplan, an investigational, targeted C3 therapy for treating ge...
The Alliance for Natural Health calls on FDA to require a Boxed Warning for proton pump inhibitors on the risk of dementia associated with regular use...