11. The White House. “Memorandum for the Secretary of Health and Human Services and the Commissioner of Food and Drugs.” September 2025. Directs federal agencies to ensure truthful and balanced DTC drug advertising.
12. Gardner Law Firm. “FDA Sends 100+ Cease-and-Desist Letters: A Warning to Industry on DTC Pharmaceutical Advertising.” 2025. Notes the sharp increase in enforcement compared to prior years.
13. Reuters. “U.S. FDA Chief Says Hims & Hers Super Bowl Ad Violated Drug Promotion Rules.” September 12, 2025. Reports regulatory concerns over Super Bowl weight-loss drug advertising.
14. Pharmaceutical Technology. “Lilly, Novo, Hims Get FDA Warnings About Misleading Drug Communications.” 2025. Details warning letters related to promotional communications.
15. Kim, Jong-Hee, et al. “Patient-Customized Oligonucleotide Therapy for a Rare Genetic Disease.” New England Journal of Medicine 381 (2019): 1644–1652. Describes the development and administration of milasen for Batten disease.
16. Boston Children’s Hospital. “Custom Genetic Treatments and the Future of N-of-1 Medicine.” 2022. Discusses development costs and logistical challenges for individualized antisense therapies.