FDA issues Zydus Lifesciences a four-item Form FDA-483 after inspecting the firms manufacturing facility (Matoda, Gujarat, India).
FDA grants Soligenix an orphan drug designation for the active ingredient in MarVax vaccine against MARV infection.
Fresenius Kabi USA recalls (Class 1) its large-volume pump software of the Ivenix Infusion System due to software anomalies that have the potential to...
FDA classifies a December inspection at Sun Pharmaceutical Industries Dadra, India facility as official action indicated.
FDAs Oncologic Drugs Advisory Committee unanimously votes (12 to 0) that the totality of data are adequate to support the use of minimal residual dise...
Enlivex Therapeutics reports mixed results from its Phase 2 study of Allocetra in patients with sepsis.
FDA grants PureTech Health a fast-track designation for LYT-200 in combination with anti-PD1 therapy for treating recurrent/metastatic head and neck s...
FDA grants 16 Bit Inc. a de novo marketing authorization for Rho, an AI-enabled software device aimed at improving osteoporosis screening.
