The Committee on Foreign Investment in the United States recently broadened its coverage of biotechnology transactions via new regulations that became effective on November 10, 2018. This article provides perspectives about how broadly these new rules will affect the biotech industry. All parties to cross-border transactions involving US biotech businesses, whether mere licensing arrangements or full M&A, should carefully consider all US regulatory implications, including application of the new CFIUS rules, US export controls and related requirements. Parties to pending biotech transactions or contemplating future biotech transactions are well advised to take actions.