RAPT Therapeutics closes and unblinds two Phase 2 trials of zelnecirnon following FDA clinical holds due to liver failure in one patient reported earl...
BIO asks FDA to hold more discussions on a draft guidance on collecting racial and ethnicity data in clinical trials and studies.
DuVal & Associates asks the Supreme Court to hear an appeal of a 1st Circuit Court of Appeals decision upholding the conviction of two former Acclaren...
During a Senate Appropriations hearing, FDA commissioner Robert Califf tells lawmakers that the agency is advising against enriched enrollment studies...
FDA accepts for review a Bristol Myers Squibb BLA for a subcutaneous formulation of Opdivo (nivolumab) across all previously approved adult solid tumo...
Tandem Diabetes Care recalls its t:connect mobile app (version 2.7) on the Apple iOS platform that is used with the companys t:slim X2 insulin pump.
Federal Register notice: FDA announces a 6/4 Psychopharmacologic Drugs Advisory Committee meeting to discuss a Lykos Therapeutics NDA for midomafetami...
CBER director Peter Marks says FDA is working to achieve 90% correct decisions on gene therapy accelerated approvals.
