FDA grants CERo Therapeutics fast track status for CER-1236 and its use for treating acute myeloid leukemia.
Johns Hopkins drug safety expert G. Caleb Alexander says FDAs recent use of ad hoc expert panels in place of traditional advisory committees risks und...
FDA commissioner Marty Makary says an evaluation of reports contained in the agencys vaccines adverse event database shows there have been Covid-19 va...
BioNTech and Duality Biologics report that trastuzumab pamirtecan met its primary endpoint in a pivotal Phase 3 trial for patients with HER2-positive ...
FDA says an advisory committee is not needed to discuss the Aquestive NDA for Anaphylm to treat severe allergic reactions.
FDA extends by three months its review of Agios Pharmaceuticals supplemental NDA seeking to expand the use of Pyrukynd (mitapivat) to adults with thal...
FDA grants breakthrough therapy designation to Lillys oloromasib for certain lung cancers.
FDA releases the form FDA-483 containing 14 observations from an inspection at the GenoGenix outsourcing facility in Boca Raton, FL.
