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...
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...
Federal Register final rule: FDA amends certain medical device classification regulations to exclude certain software functions from the definition of...
Federal Register notice: FDA clarifies that despite enforcement discretion efforts during the Covid-19 pandemic, Class 1 surgeon and patient examinati...
FDA approves Bristol-Myers Squibbs Opdivo (nivolumab) for combination use with chemotherapy for the initial treatment of patients with advanced or met...
Becton Dickinson recalls (Class 1) its CareFusion 303 Alaris Pump Module because of the risk of the keypad lifting up due to fluid entry.