Business ❯ Pharmaceutical Industry ❯ Clinical Trials

Regulatory Affairs

FDA Inspections FDA Designations Drug Development FDA Approval Novartis FDA Approval Process FDA Applications

Lilly Will Seek FDA Approval for Retatrutide in Q1 2027 After Two More Positive Phase 3 Trials

Unclear cardiovascular signals together with unfinished manufacturing checks could shape regulators' verdict on Lilly's application.

Pluvicto Added to Standard Care Extends rPFS in PSMA-Positive Metastatic Hormone-Sensitive Prostate Cancer

Phase 3 Trial Finds Tukysa Improves PFS in First-Line Maintenance for HER2-Positive Metastatic Breast Cancer