Category
North America
Coverage of the United States and Canada: coverage determinations, drug pricing policy, regulatory decisions and the assessment bodies that inform them.
354 articles in this topic.
Articles in this category

11/13/2026
ACS Updates Prostate Cancer Screening Guideline for PSA Testing
"The American Cancer Society has updated its prostate cancer screening guideline, with regular PSA testing for average-risk men aged 50 to 69." #SyenzaNews #ProstateCancer
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11/12/2026
Aspen Gets Approval for Generic Semaglutide in Brazil and South Africa
Aspen Pharmacare has received approval for generic semaglutide in Brazil and South Africa, following Canada in July. Launches in all three markets are expected over the coming months. #SyenzaNews #MarketAccess
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11/12/2026
US MFN Drug Pricing: A 25% German Price Rise Would Cut Medicaid Savings by 3.8%
A preprint led by Thomas Hwang models how German price changes affect US Medicaid MFN savings and German statutory health insurance spending.
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11/10/2026
FDA Adds Warning on NAION Risk with GLP-1 Receptor Agonists
FDA is requiring every GLP-1 receptor agonist label to carry a warning on NAION, a rare eye condition that can cause permanent vision loss. #SyenzaNews #drugsafety #GLP1
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11/10/2026
Factor XIa Inhibitor for Stroke Prevention: FDA Approves Sunharbo
The FDA approved Sunharbo (asundexian), the first factor XIa inhibitor for stroke prevention, for adults after a recent ischemic stroke or high-risk TIA. #SyenzaNews #MarketAccess
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11/9/2026
CMS Finalizes GLOBE Model Drug Pricing for Medicare Part B Drugs
CMS finalizes the GLOBE Model drug pricing rule, benchmarking Medicare Part B drug rebates against international prices from April 2027. #SyenzaNews #MarketAccess
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11/9/2026
Medicare drug price negotiation: CMS sets permanent rules
The final rule also covers a temporary price floor for small biotech drugs and Part D plan payments to dispensing entities. #SyenzaNews #DrugPricing #MarketAccess
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11/9/2026
Zepbound and Foundayo telehealth access via Hims & Hers
Eli Lilly and Hims & Hers Health agreed to widen Zepbound and Foundayo telehealth access, with self-pay prices starting at $149 per month. #SyenzaNews #obesity #telehealth
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11/4/2026
State AI Liability in Health Care: Lawsuits Test Insurers, Apps and Chatbots
A Congressional Research Service sidebar maps the state lawsuits over AI in health care, from insurer claim denials to wellness apps and chatbots.
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11/3/2026
Mayo Clinic’s TV question for the home blood pressure monitor
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.
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11/3/2026
Global Drug Regulators Summit in Seoul Takes Up AI and Animal Testing Alternatives
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
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11/3/2026
FDA Potency Assurance Guidance: What It Asks of Cell and Gene Therapy Makers
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
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