Syenza News — health technology assessment, market access and health economics
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
Recent Posts
Factor XIa Inhibitor for Stroke Prevention: FDA Approves Sunharbo
Nov 10
Neuquén Health Technology Assessment Agency: What Law 3563 Sets Up
Nov 10
Enzutrix Patent Dispute Heads to Constitutional Court: Hearing Set for 23 November
Nov 10
CMS Finalizes GLOBE Model Drug Pricing for Medicare Part B Drugs
Nov 9
Medicare drug price negotiation: CMS sets permanent rules
Nov 9Syenza's Top Picks
Hybrid healthcare hub in Portugal: ULSSM, Medtronic join forces
Oct 29, 2026
Generic lenacapavir HIV prevention gets FDA tentative approval
Nov 3, 2026
PBS Strategic Agreements: What Government and Industry Told Patients Before the Next Deal
Nov 2, 2026
EMA Opens Deanxit Safety Review Over Movement and Memory Side Effects
Nov 2, 2026
FDA Grants Accelerated Approval to Voceryq for Recurrent Respiratory Papillomatosis
Nov 2, 2026
Migraine Medicines in Portugal: Patients Pay 61% of the Outpatient Bill
Nov 2, 2026
Latest News
Clinical Practice
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
Asia
M72 tuberculosis vaccine approval in Indonesia: BPOM weighs a fast track
BPOM is drafting a conditional approval route for the M72 TB vaccine and a joint review with the European Medicines Agency, ahead of Phase 3 results.
Cost Effectiveness Analysis Free account
Refixia Nonacog Beta Pegol: INFARMED Recommends Funding for Children Under 12 With Haemophilia B
INFARMED recommends public funding for Refixia nonacog beta pegol in children under 12 with haemophilia B, based on two single-arm trials. #SyenzaNews #MarketAccess
Clinical Practice
Recent Zolgensma safety concerns: what Novartis has reported
SMA Europe has relayed Novartis’s figures on tumour reports in patients previously treated with Zolgensma, including two cases of vector DNA integration.
Cost Effectiveness Analysis Free account
Dupilumab Chronic Spontaneous Urticaria: G-BA Finds No Proven Added Benefit
The G-BA has found no proven added benefit for dupilumab in chronic spontaneous urticaria, compared with omalizumab plus second-generation H1 antihistamines.
Artificial Intelligence And Machine Learning Free account
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.
Europe Free account
EMA Mid-Year Report 2026: Reform, Supply and the First Joint Clinical Assessment
The EMA mid-year report 2026 records 485 scientific advice requests in the first half, the first joint clinical assessment under the HTA Regulation and progress on the new pharmaceutical law. #SyenzaNews #MarketAccess
Clinical Practice
Truqap prostate cancer withdrawal: AstraZeneca pulls EU bid
“Truqap prostate cancer withdrawal: AstraZeneca pulled its EU bid for newly diagnosed use after EMA raised benefit-risk concerns.” #SyenzaNews #MarketAccess
Cardiovascular And Metabolic Diseases
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.
Cost Effectiveness Analysis Free account
Second Cochlear Implant Now Covered for Adults in the Netherlands
The Dutch health institute Zorginstituut Nederland has concluded that a second cochlear implant for adults with severe hearing loss in both ears belongs in the basic health package. #SyenzaNews #MarketAccess
Value Science Weekly
The week in health technology assessment, market access and health economics — what moved, and what it means.
