- In January 2025, UroGen Pharma Ltd. announced that the FDA accepted the New Drug Application (NDA) for UGN-102, assigning a Prescription Drug User Fee Act (PDUFA) goal date of June 13, 2025. UGN-102 is being developed for the treatment of patients with low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
- In October 2024, Gilead Sciences announced the voluntary withdrawal of its drug Trodelvy for treating metastatic urothelial cancer in the U.S. after a confirmatory trial failed to meet its primary endpoint. The decision was made in consultation with the U.S. FDA, following the drug's inability to improve survival rates and an observed higher number of deaths due to complications compared to alternative therapies.
- In December 2024, AbbVie received regulatory approval for a dual-action monoclonal antibody for inflammatory bowel disease in both U.S. and European markets. This approval enhances AbbVie's immunology portfolio and offers new treatment options for patients.
- In February 2025, Novartis announced the launch of a first-in-class gene therapy for a rare autoimmune skin condition, expanding its specialty biologics portfolio. This move signifies Novartis's commitment to advancing gene therapy treatments.
