FDA issues an updated guidance entitled E6(R3) Good Clinical Practice (GCP) that describes GCP principles, emphasizing flexible, modern approaches to ...
New trial data show Eli Lillys Jaypirca (pirtobrutinib) significantly extended progression-free survival in previously untreated patients with chronic...
Merck reports favorable results from the IDeate-Lung01 Phase 2 trial showing that ifinatamab deruxtecan demonstrated clinically meaningful response ra...
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...
