[ Price : $8.95]
FDA approves a Celltrion BLA for Omlyclo, the first interchangeable biosimilar to Genentechs Xolair (omalizumab).[ Price : $8.95]
FDA denies a hearing on Vandas Hetlioz sNDA and proceeds with its rejection of the filing.[ Price : $8.95]
FDA says a Nuwellis 12/2024 recall of certain lots of its extracorporeal blood circuits is Class 1.[ Price : $8.95]
FDA approves a Neurotech Pharmaceuticals BLA for Encelto (revakinagene taroretcel-lwey) for treating macular telangiectasia Type 2...[ Price : $8.95]
Medtronics Micro Therapeutics unit recalls its Pipeline Vantage Embolization Device with Shield Technology after it determined tha...[ Price : $8.95]
FDA approves a scPharmaceuticals supplemental NDA for Furoscix (furosemide injection) to expand the indication to include treatmen...[ Price : $8.95]
FDA reports on a 2024 workshop on using dynamic tools to enhance new drug development efficiency.[ Price : $8.95]
FDA approves both Breakthrough Device and Targeted Acceleration Pathway designations for Phantom Neuros Phantom X platform that co...