Recent and anticipated novel drug approvals (4Q 2024 through 3Q 2025).

PURPOSE: Health-system pharmacists play a crucial role in monitoring the pharmaceutical pipeline to manage formularies, allocate resources, and optimize clinical programs for new therapies. This article aims to support pharmacists by providing updates on new and anticipated novel drug approvals.

SUMMARY: Selected drug approvals anticipated in the 12-month period covering the fourth quarter of 2024 through the third quarter of 2025 are reviewed. The analysis emphasizes drugs expected to have significant clinical and financial impact in hospitals and clinics, as selected from among 51 novel drugs awaiting US Food and Drug Administration approval. New drugs for severe rare diseases, cancers, autoimmune diseases, acute pain, and reversal of anticoagulation are being developed. Additionally, a new cell therapy for treatment of graft-versus-host disease joined the group of novel targeted therapies for various diseases awaiting approval.

CONCLUSION

Novel therapies for treating rare diseases and cancers continue to strengthen the current drug pipeline.