Ionis Pharmaceuticals and its affiliate Akcea Therapeutics receive an FDA complete response letter rejecting an NDA for Waylivra (volanesorsen), indic...
CDER promotes Office of Strategic Programs deputy director Mary Slack to permanent director.
FDA tells four more online networks operating 21 Web sites to stop selling unapproved and misbranded versions of opioid drugs.
Keryx asks FDA to recognize two forms of exclusivity for its Auryxia ferric citrate drug.
FDA clears a Ceterix Orthopedics 510(k) for an added feature to the NovoStitch Pro Meniscal Repair System a size 0 suture cartridge.
Haemonetics recalls 10 lots of their Leukotrap RC System with RC2D Filter, intended for collecting whole blood and preparation of red blood cells and ...
CDERs Office of Prescription Drug Promotion says a professional sell sheet for Ascends EstroGel contains false and misleading claims that it contains ...
Representatives of innovator and generic drug companies disagree on the value of a 10-year drug exclusivity provision in the trade agreement with Mexi...