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...
CBER says Regenerative Solutions of New Jersey is marketing unapproved exosome drug products for a variety of diseases and conditions, including Covid...