Consultants from Eliquent Life Sciences say most of FDAs drug inspection-based Warning Letters issued in fiscal year 2024 went to domestic firms, alth...
FDA approves a Celltrion BLA for Omlyclo, the first interchangeable biosimilar to Genentechs Xolair (omalizumab).
FDA denies a hearing on Vandas Hetlioz sNDA and proceeds with its rejection of the filing.
FDA says a Nuwellis 12/2024 recall of certain lots of its extracorporeal blood circuits is Class 1.
FDA approves a Neurotech Pharmaceuticals BLA for Encelto (revakinagene taroretcel-lwey) for treating macular telangiectasia Type 2 (MacTel), a neurode...
Medtronics Micro Therapeutics unit recalls its Pipeline Vantage Embolization Device with Shield Technology after it determined that the use of the emb...
FDA approves a scPharmaceuticals supplemental NDA for Furoscix (furosemide injection) to expand the indication to include treatment of edema in patien...
FDA reports on a 2024 workshop on using dynamic tools to enhance new drug development efficiency.