A federal court struck down the FDA’s final rule to regulate lab‑developed tests (LDTs) in 2025, marking the year’s most consequential regulatory decision and halting the agency’s attempt to extend oversight, industry analysts say. The ruling followed legal challenges that argued the FDA overstepped statutory authority in regulating LDTs. The LDT decision, together with struggles to regulate AI in diagnostics and therapeutics, dominated the regulatory landscape and will shape how companies validate, market, and postmarket‑monitor novel laboratory tests. The ruling has immediate operational implications for clinical laboratories and diagnostic firms that had begun compliance efforts. Separately, trade and pricing policies in 2025 — including contentious negotiations on EU pharmaceutical legislation — put additional pressure on industry stakeholders, compounding regulatory uncertainty across geographies.