FDA Authorizations & Approvals Impacting Mammograms and HIV Prevention
On June 5, 2025, the U.S. Food & Drug Administration (FDA) granted De Novo authorization to Clairity Breast, the first-ever AI-powered platform that predicts a woman’s risk of developing breast cancer over the next five years—using only a standard mammogram. De Novo authorization is especially meaningful as it marks the very first platform of its kind.
Unlike current risk models—which depend on factors like age, family history, or self-reported questionnaires, Clairity Breast analyzes the mammogram itself. The platform uses advanced artificial intelligence to detect subtle imaging patterns in breast tissue that correlate with future cancer development, even if the mammogram appears normal to the human eye. This results in a validated five-year risk score that can guide personalized follow-up care before any sign of disease appears.
On June 18, 2025, the FDA approved lenacapavir (Yeztugo) as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in at-risk adults and adolescents. This is the first and only twice-yearly PrEP option available in the U.S.
Gilead Sciences, the manufacturer, said it is working closely with insurers, health care systems, and other payers to ensure access for lenacapavir. Co-pays may be zero for some individuals with or without commercial insurance.
The long-acting injection is also approved for HIV treatment under the brand name Sunlenca.