Montana passed SB535, a biotech law allowing physicians to administer experimental treatments outside trials if they completed FDA Phase 1, received approval from a state review board, and are delivered at licensed clinics with enhanced consent. The law uniquely permits sponsors and clinics to charge for treatment, addressing the "Valley of Death" funding gap where promising drugs stall between early trials and commercial investment.
The American Medical Association has passed a resolution to classify nearsightedness as a disease, supporting insurance coverage for treatments that slow its progression in children. With nearly 42% of Americans now nearsighted and the WHO predicting 50% global prevalence by 2050, the policy aims to increase access to FDA-approved interventions including special eyeglasses, contact lenses, and eye drops that can prevent serious vision complications.
The FDA has cleared the iLet Bionic Pancreas, a wearable automated insulin delivery device developed in a Boston University lab by biomedical engineering professor Ed Damiano. The device, inspired by Damiano's son's type 1 diabetes diagnosis, can deliver tailored insulin doses every five minutes and is now available for people aged six and older with the chronic condition.