NewAmsterdam Pharma doses first participant in SPINOZA Phase 2b trial of obicetrapib for preclinical Alzheimer's disease, ...

Federal government outlines four regulatory changes for IRB oversight affecting multisite studies, protocol reviews, and ...

Iopofosine I 131 achieved 79% major response in BTK inhibitor-refractory Waldenström macroglobulinemia patients in Phase 2b ...

Vanda's tasimelteon meets Phase III endpoint in delayed sleep-wake disorder, advancing 60% of patients' sleep onset by 30+ ...

AbbVie's zumilokibart met all primary endpoints in Phase 2 atopic dermatitis testing, showing rapid skin and itch improvement ...

EDC query automation improves data quality only when sites can respond without being overwhelmed by low-value queries.

Novo Nordisk licenses oral GLP-1/GIP dual agonist HRS-1596 from Hengrui for $300M upfront, with potential $2.6B in milestone ...

FDA approves DEGEVMA biosimilar to Xgeva for cancer bone complications, expanding the competitive denosumab market following ...

Keros Therapeutics enrolls first patient in Phase 2 rinvatercept DMD trial to evaluate myostatin/activin inhibition for ...

FDA Single IRB Rule for multisite trials advances to final rule status in December 2026, ending parallel IRB review for ...

CIRM awards Fate Therapeutics $15M to advance FT819 lupus nephritis trial, testing allogeneic CAR T-cell therapy in patients ...

Inventiva's lanifibranor faces cash runway pressure as it awaits Phase 3 MASH data readout. Enrollment pace will determine ...