North America

A Congressional Research Service sidebar maps the state lawsuits over AI in health care, from insurer claim denials to wellness apps and chatbots.

A Mayo Clinic cardiologist's TV-set question makes the case for a home blood pressure monitor, with a caution on device reliability and home data in the chart.

The Ministry of Food and Drug Safety hosts ICMRA, the international coalition of medicines regulators, in Seoul from 3 to 6 November 2026, with AI rules and alternatives to animal testing on the agenda. #SyenzaNews #MarketAccess #drugregulation

FDA has finalized its potency assurance guidance for cell and gene therapy products. It covers lot-release testing, potency assays, acceptance criteria and how sponsors should build a strategy from the IND stage onward. #SyenzaNews #CellAndGeneTherapy #FDA

The FDA has granted accelerated approval to Voceryq, the first plasmid DNA-based immunotherapy in the US, for adults with recurrent respiratory papillomatosis.

MIT's William Bonvillian opens his innovation systems course with Solow and Romer: technology drives about two-thirds of US growth, and R&D only pays off with trained talent doing it. His prospector theory has a blunt corollary for anyone fencing off talent. #SyenzaNews #InnovationPolicy #HealthEconomics #RandD

The US Department of Labor has finalized its PBM fee disclosure rule. From plan years beginning on or after 1 July 2027, PBMs must disclose rebates, spread compensation, copay claw-backs and per-drug net prices to large self-insured ERISA plans, report twice a year, and accept an annual audit by an auditor the plan chooses. EBSA estimates $818.4 million a year in transfers from PBMs to plans and participants. #SyenzaNews #PBM #DrugPricing #MarketAccess

Lilly's TRANSCEND-T2D-2 trial found retatrutide lowered A1C more than Ozempic 2 mg and produced more than double the weight loss at 80 weeks. #SyenzaNews #clinicaltrials

Keytruda monotherapy cut the risk of progression or death by 43% against platinum chemotherapy in dMMR endometrial cancer, in the KEYNOTE-C93 Phase 3 trial. #SyenzaNews #oncology #precisionmedicine #endometrialcancer

Merck and Moderna report a 42% reduction in recurrence or death for intismeran plus KEYTRUDA in resected stage IIB-IV melanoma, with full data at ESMO 2026. #SyenzaNews #melanoma #MarketAccess

The FDA has launched the Neuroscience Advancement and Innovation Nexus, starting with an Alzheimer's Prevention Accelerator. #SyenzaNews #Alzheimers #MarketAccess

A new npj Digital Medicine article in press from SCPMG proposes the C-TACT clinical AI governance framework, with weighted lifecycle scorecards and its limits stated.