Recent actions from the FDA and NIH, including significant staff departures at FDA’s drug center and multiple funding cuts from NIH, have introduced uncertainties in the biotech research and regulatory environment. NIH program terminations, project grant cancellations, and leadership controversies signal a challenging outlook for U.S.-based biomedical research funding. Additionally, regulatory delays, stringent review processes, and increased requirements for clinical trials are affecting drug and device approvals, prompting biopharma companies to adjust pipelines and seek alternative pathways.