Life‑sciences firms ended 2025 facing regulatory turbulence as agencies shifted practices and new leadership signaled structural changes. Industry analysts described the year as marked by “chaotic uncertainty,” citing shifting FDA policy choices, contested rulemaking and a volatile enforcement environment that complicated planning for biopharma and med‑tech firms. Concurrently, the FDA explored a novel contracting mechanism to work more directly with venture‑backed small firms—seeking to cut intermediaries from traditional contracting channels. The proposed contracting changes aim to streamline agency access to emerging technologies but raise questions around procurement oversight and equity among vendors. Together, these developments create both risks and opportunities: firms must monitor policy signals closely and adapt regulatory strategies, while investors may reprice risk for programs sensitive to agency posture.