Eli Lilly hires former CBER Office of Therapeutic Products (OTP) deputy director Rachael Anatol, who was removed from her agency post and placed on ad...
FDA releases two final guidances related to biosimilar development: One on comparative analytical assessments, and the other on classification categor...
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...
