Federal Register notice: FDA makes available its decision to deny a request for a hearing on a CDER recent refusal to approve a Vanda supplemental NDA...
Johnson & Johnson stops its Phase 3 VENTURA development program evaluating aticaprant as an adjunctive treatment for major depressive disorder due to ...
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...