FDA issues Saol Therapeutics a complete response letter on its NDA for SL1009 (sodium dichloroacetate oral solution) for treating pediatric Pyruvate D...
FDA unveils a new green list import alert aimed at preventing unapproved and potentially unsafe GLP-1 drug ingredients from entering the U.S.
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 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.
