Fresenius Kabi recalls its Ivenix LVP software that is embedded in its Ivenix Infusion System due to reports about certain anomalies associated with t...
FDA grants Plus Therapeutics an orphan drug designation for Rhenium (186Re) Obisbemeda, a radiotherapy for treating leptomeningeal metastases in patie...
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.