FDA says QuVa Pharma is recalling specific lots of RECK prepared using sterile ketorolac that was recalled by Fresenius Kabi.
NIHs Anthony Fauci says new clinical data show that Gileads investigational antiviral remdesivir may block Covid-19 and lead to quicker recoveries for...
Politico reports that CBER director Peter Marks has been positioned by HHS as the governments leading expert on Covid-19 vaccine development following...
The Government Accountability Office suggests more CDRH evaluation and monitoring of FDA-authorized tests as one of eight ways the federal government ...
FDA reschedules for 6/30 a public meeting to discuss possible agency-level approaches to modernizing FDAs data strategy.
FDA clears a Personal Genome Diagnostics 510(k) for PGDx eliotissue complete, a diagnostic kit for performing genomic profiling of cancer.
FDA clears a Life Spine 510(k) to market implant and instrument additions to its ARx Spinal System.
Sanofi and Regeneron Pharmaceuticals stop a Libtayo (cemiplimab) Phase 3 trial in lung cancer early after the primary endpoint of overall survival was...