FDA Orders Postmarket Surveillance Of Certain TMJ Implants
Today the U.S. Food and Drug Administration ordered three manufacturers of temporomandibular joint (TMJ) implants to conduct postmarket surveillance studies to determine the length of time before the implants are removed or replaced due to pain or other reasons. The TMJ connects the lower jaw (mandible) to the temporal bone in the skull. A person may have an implant to replace the socket in the ...

FDA Grants Orphan Drug Designation To Regorafenib For The Treatment Of Gastrointestinal Stromal Tumors
Bayer HealthCare announced that its investigational anti-cancer compound regorafenib (BAY 73-4506) has been granted orphan drug status for the treatment of patients with gastrointestinal stromal tumors (GIST) by the U.S. Food and Drug Administration (FDA). "Despite treatment advances over the past several years, GIST remains a potentially fatal disease, and there is still a significant unmet ...