Washington Legal Foundation asks the Supreme Court to review an appeals court decision it says will make it virtually impossible to settle drug patent...
FDA provides de novo clearance for IlluminOss Medicals IlluminOss Bone Stabilization System for treating impending and actual pathological fractures o...
Pulmonx Corp. files a PMA for the Zephyr Endobronchial Valve (EBV), a removable device designed to treat severe emphysema.
FDA commissioner Scott Gottlieb hails the agencys record of drug approvals in 2017.
pSivida Corp. files an NDA for Durasert, a three-year sustained-release implant containing the corticosteroid fluocinolone acetonide for treating post...
The Trump Administration brings a big drop in FDA enforcement actions, cutting Warning Letters by 12% and inspections by 13%.
FDA accepts for review two Merck NDAs for doravirine, the companys investigational non-nucleoside reverse transcriptase inhibitor for treating HIV-1 i...
FDA clears an STS Medical 510(k) for its composite sinus stent.