Agenus files a BLA seeking accelerated approval for balstilimab, an anti-PD-1 antibody for treating patients with recurrent or metastatic cervical can...
FDA places a clinical hold on an Anixa Biosciences ovarian cancer chimeric antigen receptor-T cell therapy being developed in partnership with Moffitt...
The DC Circuit Court of Appeals affirms a lower court decision that FDA is not afforded discretion when a combination product meets the definition of ...
Pacific Research Institute senior fellow and former FDA Office of Biotechnology director Henry I. Miller says FDAs decision to recommend a pause on Jo...
Tenacore recalls Alaris Pumps it serviced because bezel repair posts may crack or separate leading to inaccurate fluid delivery.
Emergent BioSolutions, contract Covid-19 vaccine supplier to Johnson & Johnson, agrees to not manufacture bulk drug substances and to quarantine exist...
FDA sends Block Scientific a Warning Letter after reviewing its Web site and determining it is marketing Covid-19 test kits without agency approval, c...
Federal Register final rule: FDA amends certain medical device classification regulations to exclude certain software functions from the definition of...