What recent approvals reveal about evolving regulatory standards–and what sponsors must prepare for now.
The FDA’s 2025 approvals are already signaling where the agency is headed next. Shifts in evidence expectations, clinical precedent, and regulatory flexibility are beginning to reshape the path to approval for oncology and rare disease therapies.
In this edition of CMO Confidential, Dr. Harpreet Singh, Precision for Medicine Chief Medical Officer and former FDA Oncology Division Director, examines three recent approvals—Dordaviprone, Enhertu, and Itvisma—and explains what these decisions foreshadow for trial design, evidence strategy, and sponsor submissions in 2026.
What You’ll Learn
- The regulatory signals embedded in recent FDA approvals
- How standards in oncology and rare disease development are evolving
- Strategic considerations for sponsors navigating future evidence and submission
Watch the video for a regulator‑informed view of what’s changing, and why it matters for your 2026 planning.
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