Kimberly-Clark agrees to pay $40 million under a deferred prosecution agreement to resolve a criminal charge that it sold adulterated MicroCool surgic...
Former FDA commissioner Scott Gottlieb warns that HHS secretary Robert F. Kennedy Jr. may attempt to use a forthcoming HHS report on autism to challen...
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.