FDA accepts a BLA submitted by Dr. Reddys and Alvotech for a biosimilar form of Amgens Prolia and Xgeva.
FDA warns Concord, Ontario, Canada-based Vegewax Candleworx about CGMP violations in its production of finished drugs.
Smiths Medical recalls its ProPort Plastic Venous Access System because the devices plastic port housing and port reservoir may separate.
The International Council for Harmonization says the M11 and M13B guidelines have advanced to the second public consultation.
Federal Register notice: FDA updates its publication on modifications to the list of recognized consensus standards for use in device premarket review...
FDA awards Merck traditional approval for Keytruda (pembrolizumab) for use in combination with trastuzumab and chemotherapy for the first-line treatme...
FDA clears a bioMrieux 510(k) for the latest version of its Vitek Compact Pro for microorganism identification and antibiotic susceptibility testing.
Sarepta says a young man with Duchenne muscular dystrophy being treated with Elevidys has died from acute liver failure.
